Article Date: 1/1/2010

CLINICAL TRIAL UPDATE

CLINICAL TRIAL UPDATE

DRY AMD

Study: A Study of the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Intravitreal Injections of FCFD4514S in Patients With Geographic Atrophy
Sponsor: Genentech
Purpose: To study of safety tolerability pharmacokinetics, and immunogenicity of an intravitreal (ITV) injection of FCFD4514S in patients with Geographic Atrophy (GA)
Design: Treatment, Open-label, Uncontrolled, Single Group Assignment
Number of Patients: 36
Inclusion Criteria: Geographic atrophy (GA) at least 0.75 disc areas in the absence of choroidal neovascularization (CNV)
Exclusion Criteria: Treatment for active systemic infection; predisposition or history of increased risk for infection; active malignancy; history of medical conditions, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use an investigational drug or that might affect interpretation of the results of the study or that renders the patient at high risk for treatment complications; GA in either eye due to non-AMD causes; active or history of ocular and intraocular conditions in the study eye (except GA); history of vitreoretinal surgery or laser photocoagulation in the study eye; prior treatment for AMD (except vitamins and minerals); history of ITV drug delivery; intraocular surgery (including cataract surgery) in the study eye within 3 months preceding Day 0; previous participation in any studies of investigational drugs within 1 month preceding Day 0 (excluding vitamins and minerals)
Information: rossignol.natalie@gene.com

Study: COMPLETE: Complement Inhibition With Eculizumab for the Treatment of Non-Exudative Macular Degeneration (AMD)
Sponsor: University of Miami/Alexion Pharmaceuticals
Purpose: To evaluate the safety and efficacy of eculizumab for the treatment of dry AMD as evaluated by the change in drusen volume and area of geographic atrophy
Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Number of Patients: 60
Inclusion Criteria: In the study eye(s), the presence of non-exudative AMD documented by fundus photography, autofluorescence, fluorescein angiography, and spectral domain OCT; visual acuity of 20/63
Exclusion Criteria: Visual acuity worse than 20/63; Any history of choroidal neovascularization in the study eye; Unresolved meningococcal disease; Confounding ocular conditions such as amblyopia; aphakia; myopia requiring >6 D of correction
Information: (305) 326-6148

Study: TORPA: Toronto and Oak Ridge Photo-biomodulation Study for Dry Age Related Macular Degeneration
Sponsor: Graham Merry, MD
Purpose: To evaluate clinical outcomes of Photo-biomodulation treatment on patients with dry AMD
Design: Treatment, Open-label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Number of Patients: 20
Inclusion Criteria: Best corrected visual acuity between 20/40 and 20/200
Exclusion Criteria: Visually significant cataracts; presence of a visually significant posterior capsule if prior cataract has been performed
Information: (865) 483-6399

Study: Sirolimus to Treat Geographic Atrophy Associated With Age-Related Macular Degeneration
Sponsor: National Eye Institute
Purpose: To examine the safety and effectiveness of sirolimus in preserving vision in patients with geographic atrophy (GA) associated with AMD
Design: Treatment, Randomized, Open-label, Placebo Control, Single Group Assignment, Safety/Efficacy Study
Number of Patients: 15
Inclusion Criteria: Participant must have at least 1/2 disc area (approximately 1 mm2) of GA compatible with AMD present in each eye.
Exclusion Critieria: Participant has evidence of ocular disease other than AMD in either eye that may confound the outcome of the study (eg diabetic retinopathy with 10 or more hemorrhages or microaneurysms, uveitis, pseudovitelliform macular degeneration, moderate/severe myopia
Information: (800) 411-1222

Study: A Multi-Center Study of Reading Rehabilitation in Macular Disease
Sponsor: Department of Veteran Affairs
Purpose: To measure the effectiveness of a newly-designed oculomotor training program for patients with macular disease, including AMD
Design: Randomized, Double Blind (Subject, Outcomes Assessor), Crossover Assignment, Efficacy Study
Number of Patients: 120
Inclusion Criteria: Patients with a diagnosis of macular disease, such as AMD; an established preferred retinal locus; VA of less than or equal to 20/70 and greater than or equal to 20/400 (in the better eye)
Exclusion Criteria: Other major ophthalmologic and neurologic disease, CNV, moderate to severe media opacities
Information: pdgrant@uic.edu

Study: Safety And Tolerability Study Of RN6G In Patients With Dry, Age-Related Macular Degeneration
Sponsor: Pfizer
Purpose: To determine the safety and tolerability of RN6G in patients with dry AMD
Design: Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Single Group Assignment, Safety Study
Number of Patients: 45
Inclusion Criteria: Diagnosis of dry AMD as defined by the Age-Related Eye Disease Study (AREDS, 2005), including uni- or multi-focal GA, without foveal involvement; BCVA of 20/320 or better in the worst eye
Exclusion Criteria: Diagnosis of exudative (wet) AMD, with subretinal or choroidal neovascular lesions; diagnosis or history of Alzheimer's disease,
Information: (800) 718-1021

Study: Fluocinolone Acentonide Intravitreal Inserts in Geographic Atrophy
Sponsor: Alimera Sciences
Purpose: To compare the safety and efficacy of Medidur FA treatment in 1 eye to the sham-treated fellow eye of subjects with geographic atrophy secondary to AMD
Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Number of Patients: 40
Inclusion Criteria: Clinical diagnosis bilateral GA secondary to AMD of >0.5and <7 MPS disc areas; males and non-pregnant females 55 years old or older
Exclusion Critieria: GA secondary to any condition other than AMD in either eye; history of or current CNV in either eye or the need for antiangiogenic therapy; glaucoma or ocular hypertension
Information: lschulz@med.wayne.edu

Study: Weekly Vaccination With Copaxone as a Potential Therapy for Dry Age-Related Macular Degeneration
Sponsor: The New York Eye and Ear Infirmary
Information: ktai@nyee.edu

Study: Safety Study in Retinal Transplantation for Dry Age-Related Macular Degeneration
Sponsor: Ocular Transplantation; National Neurovision Research Institute
Information: nradtke@prodigy.net

Study: Study of the Safety Tolerability Pharmacokinetics and Pharmacodynamics of ACU-4429 in Subjects With Geographic Atrophy
Sponsor: Acucela, Inc.
Information: www.acucela.com

WET AMD

Study: Safety and Tolerability Study of AAV2-sFLT01 in Patients With Neovascular Age-Related Macular Degeneration (AMD)
Sponsor: Genzyme
Purpose: To examine the safety and tolerability of an experimental gene transfer agent, AAV2-sFLT01, in patients with Neovascular Age-Related Macular Degeneration (AMD)
Design: Treatment, Non-Randomized, Open-label, Parallel Assignment, Safety Study
Number of Patients: 34
Inclusion Criteria: Choroidal neovascular membrane (CNV) secondary to AMD, as confirmed by the patient's medical history and a documented diagnosis of CNV; subfoveal disciform scarring for the first part of the study (the dose-escalation part). Patients must not have subfoveal disciform scarring in the second part of the study (the maximum tolerated dose part); retinal thickness ≥ 275 μm with presence of intra- or sub-retinal fluid; adequate dilation of pupils to permit thorough ocular examination and testing; must be willing to have samples of anterior chamber fluid collected from the study eye
Exclusion Criteria: CNV in the study eye due to any reason other than AMD. Neutralizing antibody titers to AAV2 that are ≥ 1:1600; history of conditions in the study eye during Screening which might alter visual acuity or interfere with study testing; active uncontrolled glaucoma; had any intraocular surgeries in the study eye within 3 months of enrollment or are known or likely candidates for intraocular surgery (including cataract surgery) in the study eye within 1 year of treatment; acute or chronic infection in the study eye; history of inflammation in the study eye or ongoing inflammation in either eye; any contraindication to intravitreal injection
Information: medinfo@genzyme.com

Study: A Study of Intravitreal Injections of 2.0mg Ranibizumab in Subjects With Chronic Fluid On OCT Post Multiple Injections With Ranibizumab (Super-dose Anti-VEgf SAVE Trial)
Sponsor: Greater Houston Retina Center
Purpose: To determine whether 2.0 mg ranibizumab is effective in the treatment of recurrent fluid
Design: Treatment, Randomized, Open-label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Number of Patients: 50
Inclusion Criteria: The last treatment with Ranibizumab is ≥ 28 days
To have received at least 9 injections of Ranibizumab in the past 12 months; any CNVM lesion (Occult, Minimally Classic or Classic) (ie, leakage on fluorescein angiography or subretinal, intraretinal, or sub-RPE fluid on Spectral Domain OCT) secondary to age-related macular degeneration; BCVA in the study eye, using e-ETDRS testing, between 20/25 and 20/320 (Snellen equivalent), inclusive; only one eye will be enrolled in the Study. If both eyes are eligible study investigator will select the eye for entry
Exclusion Criteria: Subretinal hemorrhage in the study eye that involves the center of the fovea, if the size of the hemorrhage is either > 50% of the total area of the lesion or > 1 disc area (2.54 mm2) in size; subfoveal fibrosis or atrophy in the study eye; CNV in either eye due to other causes, such as ocular histoplasmosis, trauma, or pathologic myopia concurrent ocular conditions; retinal pigment epithelial tear involving the fovea in the study eye
Information: Karri.Shuetzle@houstonretina.com

Study: MONET: Phase II Open-label Multicenter Study For Age Related Macular Degeneration Comparing An Investigational Drug PF-04523655 Versus Lucentis In The Treatment Of Subjects With Choroidal Neovascularization
Sponsor: Pfizer/Quark Pharmaceuticals, Inc.
Purpose: To evaluate whether PF-04523655 is effective in the treatment of neovascular/wet AMD and at which dose
Design: Treatment, Randomized, Open-label, Parallel Assignment, Safety/Efficacy Study
Number of Patients: 150
Inclusion Criteria: The total area of CNV (including both classic and occult components) encompassed within the lesion must be 50% or more of the total lesion area; total lesion size ≤12 disc areas.; BCVA of 20/40 to 20/320 (letter score ≤73) in the study eye at the screening visit; BCVA in the fellow eye of 20/400 or better (letter score of <19) at the Screening Visit; Subject has retinal central subfield thickness ≥250 μm measured using Stratus OCT
Exclusion Criteria: Prior treatment with verteporfin photodynamic therapy, external-beam radiation therapy, or transpupillary thermotherapy in the study eye; previous subfoveal focal laser photocoagulation in the study eye; laser photocoagulation (juxtafoveal or extrafoveal) in the study eye within 1 month preceding Baseline; history of vitrectomy, submacular surgery or other surgical intervention for AMD in the study eye; previous participation in any studies with investigational drugs or treatments administered 1 month preceding Baseline visit such as systemic glucocorticoids, ocular or periocular steroids (eg, triamcinolone, anecortave acetate), anti-angiogenic drugs such as pegaptanib (Macugen), ranibizumab (Lucentis), bevacizumab (Avastin) in the study eye
Information: (800) 718-1021

Study: Study of Intravitreal Microplasmin in Relieving Vitreo-Macular Adhesion in Neovascular Age-related Macular Degeneration (AMD)
Sponsor: University of California-Los Angeles/ThomboGenics
Purpose: To determine whether microplasmin given by intravitreal injection is effective and safe for the treatment of wet age-related macular degeneration (AMD) in patients who have focal vitreomacular adhesion (VMA)
Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Number of Patients: 30
Inclusion Criteria: Presence of focal vitreomacular adhesion as seen by OCT; BCVA of 20/800 or better in non-study eye; presence of active choroidal neovascular membrane
Exclusion Criteria: Subjects who have previously received microplasmin; subjects with any vitreous hemorrhage or any other vitreous opacification which precludes adequate examination or investigation of study eye; patient with uncontrolled glaucoma including IOP >25 mm Hg; subjects who have had vitrectomy or retinal detachment or who are aphakic or highly myopic (>8.0 D) in the study eye
Information: ostrick@jsei.ucla.edu

Study: A Phase 1 Dose Escalation Study of PF-04523655 (REDD14NP) In Subjects With Choroidal Neovascularization (CNV) Secondary to Age-Related Macular Degeneration (Wet AMD)
Sponsor: Pfizer/Quark Pharmaceuticals, Inc.
Purpose: To evaluate whether PF-04523655 is safe in the treatment of neovascular/wet AMD
Design: Treatment, Randomized, Open-label, Single Group Assignment, Safety Study
Number of Patients: 54
Inclusion Criteria: Patient has documented CNV secondary to AMD with evidence of active disease characterized by blood vessel leakage or evidence of hemorrhage; patient has clear ocular media and adequate pupil dilation to allow good quality imaging by fundus photography; patient's intraocular pressure is ≤25 mm Hg
Exclusion Critieria: Patient has CNV due to causes other than AMD, including ocular or periocular infections; patient has lesions not easily imaged and quantified; patient has underlying systemic disease such as cardiac, neurological, infectious disease, uncontrolled diabetes mellitis, or disease of the eye other than AMD. Patient may have medically controlled glaucoma
Information: (800) 718-1021

Study: Retinal and Retinal Pigment Epithelium (RPE) Autoimmunity in Age-related Macular Degeneration (AMD) — Correlation With Lucentis(R) Therapy (Antibody)
Sponsor: University of California-Davis/Genentech
Purpose: To determine if “wet” AMD patients differ from patients with “dry” AMD or normal eyes in the production of anti-retinal pigment epithelium or anti-retinal antibody formation
Design: Treatment, Nonrandomized, Open-label, Active Control, Parallel Assignment
Number of Patients: 131
Inclusion Criteria: Age > 50 years old; patients with active neovascular “wet” AMD naïve to treatment or treated with 4 monthly injections of ranibizumab without an adequate response (decrease VA from baseline and fluid on OCT) or patients with “dry” AMD, category 2 or 3 by AREDS criteria
Exclusion Criteria: Concurrent eye disease in the study eye that could compromise visual acuity (eg, diabetic retinopathy, advanced glaucoma); previous AMD therapy; patients being treated for autoimmune or other disease with immunomodulatory drugs (ie, prednisone, infliximab, methotrexate); patients with recent (less than 6 months) ocular or systemic surgery
Information: dgtelander@ucdavis.edu

Study: A Study of Ranibizumab Administered Monthly or on an As-Needed Basis in Patients With Subfoveal Neovascular Age-Related Macular Degeneration
Sponsor: Genentech
Purpose: To study the efficacy and safety of ranibizumab injection administered intra vitreally to patients with CNV secondary to AMD
Design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment
Number of Patients: 1100
Inclusion Criteria: CNV lesions with classic CNV component, occult CNV, or with some classic CNV component are permissible
Exclusion Criteria: History of vitrectomy surgery submacular surgery, or other surgical intervention for AMD in the study eye; prior treatment with Visudyne, external-beam radiation therapy, or TTT in the study eye
Information: lane.hayley@gene.com

Study: A Phase 1 Ascending and Parallel Group Trial to Establish the Safety, Tolerability and Pharmacokinetics Profile of Volociximab (Alpha 5 Beta 1 Integrin Antagonist) in Subjects With Neovascular Age- Related Macular Degeneration
Sponsor: Ophthotech Corp.
Purpose: To evaluate the safety, tolerability and pharmacokinetic profile of volociximab intravitreous injection in subjects with subfoveal choroidal neovascularization secondary to AMD
Design: Treatment, Nonrandomized, Open-label, Dose Comparison, Single Group Assignment, Safety Study
Number of Patients: 50
Inclusion Criteria: Subfoveal choroidal neovas cularization (CNV) due to AMD (ie, predominantly classic, minimally classic or occult no classic) as documented by fluorescein angiogram
Exclusion Criteria: Any prior treatment for AMD or any intravitreal treatment for any indication in the study eye prior to the screening visit, except oral supplements of vitamins and minerals; previous or concomitant therapy with intravitreous corticosteroids; diabetic retinopathy; history or evidence of severe cardiac disease
Information: (212) 845-8214

Study: Detection of Neutralizing Antibodies in Patients Treated With Bevacizumab or Ranibizumab
Sponsor: National Eye Institute
Purpose: To measure antibody levels in the blood of people with bleeding or swelling in the retina who have or have not been treated with bevacizumab or ranibizumab
Design: Prospective
Number of Patients: 30
Inclusion Criteria: Subjects will include adults being treated for exudative AMD, or macular edema secondary to DR or venous occlusion
Exclusion Criteria: Patients who are currently receiving any form of systemic immunosuppressive or immunomodulatory therapy, including corticosteroids; patients who have autoimmune or rheumatologic disease; patients with evidence of active systemic infection
Information: prpl@mail.cc.nih.gov

Study: Study Investigating OCT, Multifocal ERG, and Microperimetry in Monthly Versus PRN Ranibizumab in Neovascular Age-Related Macular Degeneration
Sponsor: Retina Macula Institute
Purpose: To assess 2 groups (monthly and PRN therapy) and assess high resolution OCT, microperimetry, and Multi-focal ERG outcomes
Design: Treatment, Randomized, Open-label, Dose Comparison, Parallel Assignment
Number of Patients: 45
Inclusion Criteria: Age ≥50 years old; patients with active neovascular AMD
Exclusion Criteria: Participation in another simultaneous medical investigation or trial; concurrent eye disease in the study eye that could compromise visual acuity (eg, diabetic retinopathy, advanced glaucoma); previous PDT therapy; previous intravitreal steroid therapy within last 3 months; previous anti-VEGF therapy in the past month
Information: lillian.rmi@gmail.com

Study: ERG/EOG Study in AMD Patients Treated With Ranibizumab
Sponsor: Retina Center, Minnesota/Genentech Purpose: To focus on the ERG and EOG tests to evaluate retinal responses to ranibizumab treatment in AMD
Design: Case-only, Prospective
Number of Patients: 10
Inclusion Criteria: Patients to be included in the study must have AMD with CNV; BCVA between 20/20 and 20/400; lesion size less than or equal to 12 MPS disc areas
Exclusion Criteria: Media insufficient to obtain a view; other causes of CNV not related to AMD; active ocular or periocular infection; ocular surgery within 1 month prior to the study; any other condition the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated
Information: vu@retinadocs.com

Study: Clinical Trial to Explore the Safety and Efficacy of Injections of Macugen When Given Every 6 Weeks in Subjects With AMD
Sponsor: OSI/Pfizer
Information: (866) 622-8436

Study: LUV: Lucentis Utilizing Visudyne Combination Therapy in the Treatment of Age-Related Macular Degeneration
Sponsor: Novartis/Greater Houston Retinal Research
Information: http://www.houstonretina.com/

Study: A Phase I Trial of a Single Intravitreal Injection of REDD14NP to Patients With CNV Secondary to Wet AMD
Sponsor: Quark Biotech, Inc.
Information: (212) 452-6902

Study: Study of Treatment Effects of Combination Therapy of Lucentis Plus Reduced-Fluence PDT in Patients With Wet AMD
Sponsor: Barnes Retina Institute
Information: bristudies@barnesretinainstitute.com

Study: ASaP: Assessment of Safety of Intravitreal POT-4 Therapy for Patients with Neovascular Age-Related Macular Degeneration
Sponsor: Potentia Pharmaceuticals, Inc.
Information: federico@potentiapharma.com

Study: A Phase 1 Safety Study of Single and Repeated Doses of JSM6427 (Intravitreal Injection) to Treat AMD
Sponsor: Jerini Ophthalmic
Information: (919) 226-1440 x325

Study: Evaluation of Dosing Interval of Higher Doses of Ranibizumab (BGB/IST)
Sponsor: Retina Vitreous Associates, P.C.; Genentech
Information: cawh@aol.com

Study: Phase 1, Safety Tolerability and Pharmacokinetic Profile of Intravitreous Injections of E10030 (Anti-PDGF Pegylated Aptamer) in Subjects With Neovascular Age-Related Macular Degeneration
Sponsor: Ophthotech Corp.
Information: denise.teuber@ophthotech.com

Study: The MAP Study: FA/Medidur for AMD Pilot
Sponsor: Johns Hopkins University/Alimera Sciences
Information: ghafiz1@jhmi.edu

Study: Antioxidant Systems and Age-Related Macular Degeneration
Sponsor: Vanderbilt University/National Institutes of Health
Information: paul.sternberg@vanderbilt.edu

Study: High Speed Indocyanine Green Angiography Findings in Ranibizumab Treatment for Wet Age-Related Macular Degeneration
Sponsor: National Eye Institute
Information: prpl@mail.cc.nih.gov

Study: ARC1905 (ANTI-C5 APTAMER) Given Either In Combination Therapy With Lucentis 0.5 mg/Eye In Subjects With Neovascular Age-Related Macular Degeneration
Sponsor: Ophthotech Corporation
Information: dbeutelspacher@ophthotech.com

Study: Reduced Fluence PDT With Visudyne in Combination With Lucentis for Age-Related Macular Degeneration
Sponsor: Oklahoma State University Center for Health Sciences/Novartis
Information: (918) 747-7799

DIABETIC MACULAR EDEMA

Study: SAR 1118 in Human Subjects Undergoing Pars Plana Vitrectomy
Sponsor: Johns Hopkins University/SARcode Corporation
Purpose: To determine the safety, tolerability and pharmacokinetics of SAR 1118 within the anterior and posterior chamber of the eye and plasma in subjects undergoing elective vitrectomy when treated with escalating concentrations of the study drug for approximately 1 week
Design: Treatment, Randomized, Single Blind (Subject), Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Number of Patients: 30
Inclusion Criteria: Current non-smoker (last date of smoking should be at least 60 days before study enrollment); surgically eligible to undergo elective PPV including, but not limited to, epiretinal membrane, vitreomacular traction, macular holes, or retinal detachment. The elective surgery must be able to be scheduled at least 21 days in advance to allow time for screening and for initiation of study drugs
Exclusion Criteria: Vitreous hemorrhage; active retinal detachment; autoimmune disease of the anterior segment or posterior chamber including chronic keratoconjunctivitis sicca, uveitis, iritis/scleritis, blepharitis of either eye; glaucoma requiring topical medications, infectious conjunctivitis, keratitis, or endophthalmitis of either eye; prior vitrectomy or intraocular lens placement, within 90 days of Day 0
Information: oshaikh1@jhmi.edu

Study: Macular Edema Incidence/Severity Reduction With Nevanac
Sponsor: Alcon
Purpose: To determine the safety and efficacy of Nevanac for the prevention of macular edema in patients with diabetic retinopathy within 90 days following cataract surgery
Design: Prevention, Randomized, Double Blind (Subject, Investigator), Parallel Assignment
Number of Patients: 260
Inclusion Criteria: NPDR (mild, moderate or severe) in the study eye as defined by the International Clinical Diabetic Retinopathy Disease Severity Scale; central subfield macular thickness ≤320 μm in the study eye prior to cataract surgery as determined by SD-OCT and confirmed by the reading center; absence of CME or cystoid abnormalities in the study eye as detected by SD-OCT and confirmed by the reading center
Information: (800) 451-3937

Study: Pilot Study for the Evaluation of Intravitreal Infliximab in the Treatment of Diabetic Macular Edema
Sponsor: Mount Sinai School of Medicine
Purpose: To determine if intravitreal infliximab is a safe and effective treatment for macular edema secondary to diabetes
Design: Treatment, Open-label, Single Group Assignment, Efficacy Study
Number of Patients: 10
Inclusion Criteria: Participant has DME that is not amenable to treatment with laser photocoagulation or has been refractory to laser photocoagulation; participant must have a negative PPD skin test; participant must understand and sign the proto col's informed consent document; participants must have DME as defined by all of the following criteria: presence of diabetes (type I or type II) and macular edema defined as a central macular thickness of ≥250 μm on OCT; participant must have visual acuity between 20/40 and hand motions in the study eye; participant must have a steady fixation in the study eye and media clear enough for good quality imaging
Exclusion Criteria: Participant has proliferative diabetic retinopathy; participant is unable to comply with study procedures or follow-up visits; participant has multiple sclerosis or symptoms suggestive of multiple sclerosis; participant has evidence of ocular disease other than DME in either eye that may confound the outcome of the study (eg, uveitis, age-related macular degeneration, vitreomacular traction, moderate/severe myopia, etc.); participant is expected to need ocular surgery or panretinal photocoagulation in the study eye during the course of the study; participant has undergone ocuar surgery or an intravitreal/periocular steroid injection in the study eye within the past 3 months; participant has had a YAG aser capsulotomy or intravitreal anti-VEGF treatment in the study eye within the past 6 weeks
Information: rojeoktay.kacmaz@mssm.edu

Study: A Clinical Safety and Efficacy Comparison of NEVANAC 0.1% to Vehicle After Cataract Surgery in Diabetic Retinopathy Patients
Sponsor: Alcon Research
Purpose: To determine whether nepafenac is safe and effective for reducing the incidence of macular edema following cataract surgery in diabetic retinopathy patients
Design: Prevention, Randomized, Double Blind (Subject, Investigator), Parallel Assignment
Number of Patients: 260
Inclusion Criteria: Patients with nonproliferative diabetic retinopathy (mild, moderate or severe) and planned cataract extraction by phacoemulsification
Exclusion Criteria: Central subfiled macular thickness >250 μm; CME in either eye
Information: (888) 451-3937

Study: Near-Infrared Light (NIR) Therapy for Diabetic Macular Edema: A Pilot Study
Sponsor: Medical College of Wisconsin
Purpose: To examine the use of NIR because it has been approved as a non-significant risk (NSR) device for treatment of eye disorders, it has a low cost of treatment, and it may serve as an effective, noninvasive alter native or adjunctive treatment to laser photo coagulation, the current standard of care for DME
Design: Nonrandomized, Open-label, Safety/ Efficacy Study, Single Group Assignment, Treatment
Number of Patients: 20
Inclusion Criteria: Age ≥18 years Subjects <18 years old are not being included because DME is so rare in this age group that the diagnosis of DME may be questionable; diagnosis of diabetes mellitus (type 1 or type 2); at least 1 eye meets the study eye criteria; fellow eye meets criteria; any candidate identified by a study investigator as being able to successfully tolerate a 3-month deferral of laser photocoagulation
Exclusion Criteria: Significant renal disease, defined as a history of chronic renal failure requiring dialysis or kidney transplant; subjects in poor glycemic control who, within the last 4 months, initiated intensive insulin treatment (a pump or multiple daily injections) or plan to do so in the next 4 months should not be enrolled
Information: hwhelan@mcw.edu

Study: Safety and Efficacy of a New Treatment in Vitrectomized Subjects With Diabetic Macular Edema
Sponsor: Allergan
Purpose: To evaluate the safety and efficacy of the intravitreal dexamethasone implant in the study eye of vitrectomized subjects with DME
Design: Nonrandomized, Open-label, Safety/ Efficacy Study, Single Group Assignment, Treatment
Number of Patients: 40
Inclusion Criteria: 18 years of age or older with DME, history of vitrectomy, central retina thickness ≥275 μm, VA between 20/320 and 20/40 in the study eye and no worse than 20/200 in the other eye
Exclusion Criteria: Known anticipated need for ocular surgery during the study period, history of glaucoma or current high eye pressure requiring more than 1 medication, uncontrolled systemic disease
Information: clinicaltrials@allergan.com

Study: Study Comparing Two Doses of Ranibizumab in the Treatment of Clinically Significant Diabetic Macular Edema
Sponsor: Long Island Vitreoretina Consultants
Purpose: To evaluate the safety and tolerability of ranibizumab in patients with clinically significant diabetic macular edema (CSDME). It will also compare treatment outcomes for patients receiving 0.5 mg ranibizumab to those receiving 1.0 mg ranibizumab
Design: Treatment, Randomized, Single Blind (Subject), Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Number of Patients: 50
Inclusion Criteria: Type 1 or Type 2 diabetic subjects; vision between 20/20 and 20/400; presence of CSDME
Exclusion Criteria: Presence of any condition that would prevent clear visualization of the back of the eye; uncontrolled glaucoma; inflammation inside the eye; certain prior eye surgeries, other than cataract surgery; other eye diseases that may compromise the vision in the study eye
Information: mschlameuss@longislandretina.com

Study: Safety and Tolerability of NOVA63035 “Corticosteroid” in Patients With Diabetic Macular Edema Secondary to Diabetic Retinopathy
Sponsor: Novagali Pharma
Information: mourad.amrane@novagali.com

Study: Intravitreal Ranibizumab to Treat Macular Edema After Panretinal Photocoagulation (Phase II)
Sponsor: Genentech/Michael J. Jumper
Information: jrose@westcoastretina.com

Study: Intravitreal Infliximab for Diabetic Macular Edema (DME) and Choroidal Neovascularization (CNV) (ITVR)
Sponsor: Retina Research Foundation
Information: (518) 533-6550

Study: Sirolimus to Treat DME
Sponsor: National Eye Institute
Information: (800) 411-1222

Study: DEGAS: Prospective, Randomized, Multi-Center, Comparator Study Evaluating Efficacy and Safety of PF-04523655 Versus Laser in Subjects With DME
Sponsor: Pfizer
Information: (800) 718-1021

RETINAL VEIN OCCLUSION

Study: Impact of Lucentis on Psychological Morbidity in Patients With Retinal Vein Occlusion
Sponsor: Retina Associates of Cleveland, Inc./ Genentech
Purpose: To study the impact of intravitreally administered ranibizumab (Lucentis) treatment on vision-related functioning and emotional well-being in subjects with central or branch retinal vein occlusion
Design: Treatment, Non-Randomized, Open-label, Parallel Assignment, Efficacy Study
Number of Patients: 45
Inclusion Criteria: Evidence of central retinal vein occlusion, defined as documented retinal hemorrhage into all four quadrants with dilated veins, or branch retinal vein occlusion, as documented on clinical exam; age 18 years or over; central macular edema on clinical exam as well as imaging with a central thickness of ≥ 250μm; visual acuity ranging from 20/8000 to 20/40; media clarity and patient cooperation sufficient to allow adequate testing utilizing OCT and FA
Exclusion Criteria: Acute illness or cognitive or other impairment that, in the opinion of the investigator, would interfere with study requirements; concurrent ocular conditions likely to significantly compromise vision and contribute the macular compromise; history of grid/focal laser in the study eye; history of vitreal surgery; previous treatment with triamcinolone acetonide or anti-VEGF agents in either eye
Information: retina@retinaassoc.com

Study: RELATE: Ranibizumab DosE Comparison and the Role of LAser in REtinal Vein Occlusions
Sponsor: Johns Hopkins University/Genentech
Purpose: To evaluate the safety and tolerability of intraocular injections of 0.5 or 2.0 mg of ranibizumab in patients with macular edema due to retinal vein occlusion
Design: Treatment, Randomized, Open-label, Parallel Assignment, Safety Study
Number of Patients: 80
Inclusion Criteria: Diagnosis of macular edema due to central or branch retinal vein occlusion; foveal thickness of equal to or greater than 250 mm, as assessed by OCT; BCVA score in the study eye of 20/40 to 20/400 inclusive (Snellen equivalents using the ETDRS protocol at a distance of 4 meters). Only one eye will be treated in the study. If both eyes are eligible, the investigator will select the eye to be enrolled; in the opinion of the investigator, decreased vision in the study eye is due to foveal thickening from vein occlusion and not from other obvious causes of decreased vision
Exclusion Criteria: Scatter laser photocoagulation or macular photocoagulation within 3 months of study entry in the study eye; intraocular surgery in the study eye within 3 months of study entry; use of intraocular or periocular injection of steroids in the study eye (eg, triamcinolone) within 4 months of study entry; previous use of an anti-VEGF drug within 3 months of study entry; cataract surgery in the study eye within 3 months of study entry; Yttrium-Aluminum-Garnet (YAG) laser capsulotomy within 1 month of study entry; or any other intraocular surgery within 3 months preceding Day 0
Information: ghafiz@jhmi.edu
Study: FAVOR: Fluocinolone Acetonide Intravitreal Inserts for Vein Occlusion in Retina
Sponsor: Alimera Sciences
Purpose: To assess the safety and efficacy of FA Intravitreal Inserts in subjects with macular edema secondary to RVO
Design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment
Number of Patients: 20
Inclusion Criteria: Diagnosis of macular edema due to branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO); central subfield thickness >300 μm; BCVA of ≥24 and ≤68 letters
Exclusion Critieria: Macular edema secondary to any condition other than RVO; presence of foveal atrophy, dense pigmentary changes or dense subfoveal exudates in the study eye; cystic intraretinal hemorrhage involving the fovea in the study eye that is responsible for vision loss; glaucoma or ocular hypertension (IOP >21 mm Hg or concurrent therapy at screening with IOP-lowering agents); any prior treatment with intravitreal, subtenon, or periocular steroid or anti-VEGF therapy since the diagnosis of RVO in the study eye; any change in systemic steroid therapy within 3 months of screening; history of vitrectomy in the study eye
Information: Kathleen.billman@alimerasciences.com

Study: Vascular Endothelial Growth Factor (VEGF) Trap-Eye: Investigation of Efficacy and Safety in Central Retinal Vein Occlusion (CRVO)
Sponsor: Regeneron Pharmaceuticals/Bayer
Purpose: To determine the efficacy of VEGF Trap-Eye injected into the eye on vision function in subjects with macular edema as a consequence of central retinal vein occlusion
Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Number of Patients: 165
Inclusion Criteria: Subjects at least 18 years of age with center-involved macular edema secondary to CRVO with mean central retinal thickness ≥ 250 μm on OCT; ETDRS best corrected visual acuity of 20/40 to 20/320 (73 to 24 letters) in the study eye
Exclusion Criteria: Previous treatment with anti-angiogenic drugs in the study eye (Pegaptanib sodium, anecortave acetate, bevacizumab, ranibizumab, etc.); prior panretinal laser photocoagulation or macular laser photocoagulation in the study eye
Information: suzanne.bates@parexel.com

Study: A Study of a Sustained Release Fluocinolone Implant for Treatment of Central Retinal Vein Occlusion
Sponsor: Duke University/Bausch & Lomb, Inc.
Purpose: To determine whether a fluocinolone sustained drug delivery implant is effective in the treatment of CRVO that has caused persistent macular edema and decreased visual acuity
Design: Treatment, Nonrandomized, Open-label, Single Group Assignment
Number of Patients: 30
Inclusion Criteria: A history of central retinal vein occlusion that had caused macular edema, based on clinical evaluation and demonstrated on fundus photography, fluorescein angiography, and OCT
Exclusion Criteria: Patients are excluded if they have an allergy to fluocinolone acetonide or any component of the delivery system, a peripheral retinal detachment in the area of implantation
Information: (919) 684-4458

Study: Effectiveness and Safety of Niacin and a Topical Steroid to Treat Retinal Vein Occlusions
Sponsor: Palo Alto Medical Foundation
Status: Currently enrolling
Purpose: To determine whether niacin, a B vitamin, may act as a vasodilator to encourage earlier formation of collateral blood vessels that may serve to bypass the obstructed vein in the eye
Design: Treatment, Nonrandomized, Open-label, Active-control, Single-group Assignment, Safety/Efficacy Study
Number of Patients: 68
Inclusion Criteria: Patient must have central retinal vein occlusion, hemi-retinal vein occlusion or branch retinal vein occlusion
Exclusion Criteria: Active gout or high levels of uric acid
Information: gaynonM@pamf.org

Study: Evaluation of Macugen Treatment of Macular Edema Due to Branch Retinal Vein Occlusion
ponsor: Palmetto Retina Center, LLC; Pfizer; OSI Pharmaceuticals
Status: Currently enrolling
Purpose: Study is to evaluate the effect of intravitreal injections of Macugen every 6 weeks for the treatment of macular edema secondary to branch retinal vein occlusion (BRVO)
Design: Treatment, Randomized, Open-label, Uncontrolled, Parallel Assignment, Safety/ Efficacy Study
Number of Patients: 30
Inclusion Criteria: Macular edema secondary to BRVO involving the foveal center in male or female patients at least 18 years of age; duration of BRVO macular edema less than 6 months prior to baseline visit; best corrected ETDRS VA 20/40 to 20/320 (Snellen equivalent) using the 4 meters testing method; central foveal thickness ≥250 μm using the OCT-3; <25% of foveal capillary ring disruption; <2 disc areas of capillary nonperfusion within 1000 μm of the foveal center; absence of hemorrhage or lipid in the foveal center
Exclusion Criteria: Ocular conditions other than BRVO-related macular edema such as sig nifi cant cataract, diabetic retinopathy, AMD, glaucoma, uveitis, epiretinal membrane, vitreomacular traction or tumor; intraocular surgery within past 3 months; significant enlargement of foveal avascular zone (>25% disruption of capillary ring) or greater than 2 disc areas of nonperfusion within 1000 μm of foveal center
Information: jackwells@palmettoretina.com

Study: Fluocinolone Acetonide Implant for Retinal Vein Occlusion (RVO)
Sponsor: Duke University; Bausch & Lomb
Status: Currently enrolling
Purpose: To determine whether a fluocinolone acetonide sustained drug delivery implant is effective in the treatment of RVO that has caused persistent macular edema and decreased visual acuity
Design: Treatment, Nonrandomized, Open-label, Uncontrolled, Single-group Assignment, Safety/Efficacy Study
Number of Patients: 30
Inclusion Criteria: A history of retinal vein occlusion that had caused macular edema, based on clinical evaluation and demonstrated on fundus photography, fluorescein angiography and OCT; macular edema at least 1 disc area in size that involved the fovea; males and nonpregnant females at least 18 years of age; IOP controlled at <21 mm Hg with no more than 1 topical ocular antihypertensive agent; initially
Exclusion Criteria: Patients are excluded if they have an allergy to fluocinolone acetonide or any component of the delivery system, a peripheral retinal detachment in the area of implantation, or media opacity precluding evaluation of study eye status
Information: (919) 684-4458

Study: Intravitreal Ranibizumab Treatment of Central Retinal Vein Occlusion With Macular Edema
Sponsor: Vitreous-Retina Macula Consultants
of New York/Genentech
Status: Enrolling patients
Purpose: To examine the effects of Lucentis for active Central Retinal Vein Occlusion with Macular Edema
Design: Treatment, Nonrandomized, Open-label, Active Control, Single Group Assignment, Safety Study
Number of Patients: 45
Inclusion Criteria: Age >18 years; clinical evidence of perfused central retinal vein occlusion (CRVO). A CRVO is defined as an eye that has retinal hemorrhages and a dilated retinal venous system in all 4 quadrants. Other evidence of a CRVO may include telangiectatic capillary bed and collateral vessels at the optic nerve head
Exclusion Critieria: Participation in another simultaneous ocular investigation or trial; uncontrolled hypertension; a condition that, in the opinion of the investigator would preclude participation in the study (ie, chronic alcoholism, drug abuse); significant diabetic retinopathy (greater than moderate NPDR) or macular edema associated with diabetic retinopathy
Information: (212) 452-6965

Study: RAVE: Rubeosis Anti-VEGF Trial for Ischemic Central Retinal Vein Occlusion
Sponsor: Greater Houston Retina Research
Information: (713) 524-3434

COMPLETED ENROLLMENT

Study: ROSE: A Study to Evaluate the Neovista Ophthalmic System for the Treatment of Subfoveal CNV in Patients With AMD That Have Failed Primary Anti-VEGF Therapy
Sponsor: NeoVista
Information: clinicaltrials@neovistainc.com

Study: A Study of Genetic and Environmental Factors and Their Effect on Response to Treatment With Lucentis (Ranibizumab) for Wet AMD
Sponsor: Oregon Health and Science University
Information: (503) 494-3616

Study: Double-Masked Study of Efficacy and Safety of IVT VEGF Trap-Eye in Subjects With Wet AMD (VIEW 1)
Sponsor: Regeneron/Bayer
Information: vegf.trap@regeneron.com

Study: Combination Ranibizumab and Bromfenac for Neovascular Age-Related Macular Degeneration
Sponsor: Oregon Health and Science University/ Genentech
Information: schainm@ohsu.edu

Study: CABERNET: Study of Strontium90 Beta Radiation With Lucentis to Treat AMD
Sponsor: NeoVista
Information: (510) 933-7650, info@neovistainc.com

Study: CATT: Comparison of Age-Related Macular Degeneration Treatments Trials: Lucentis-Avastin Trial
Sponsor: National Eye Institute
Information: dan.martin@emory.edu

Study: Infliximab, Sirolimus and Daclizumab to Treat Age-Related Macular Degeneration
Sponsor: National Eye Institute
Information: (800) 411-1222

Study: GATE: Geographic Atrophy Treatment Evaluation
Sponsor: Alcon Research
Information: medical.information@alconlabs.com

Study: Pilot Study Reduced Fluence PDT/ Visudyne With Ranibizumab vs Ranibizumab Monotherapy for Exudative Age-Related Macular Degeneration
Sponsor: Lahey Clinic
Information: Avon.P.Stewart@Lahey.org

COMPLETED STUDIES

Study: Evaluation of Safety and Efficacy of 0.3 Mg/Eye Macugen in Patients With Small Age-Related Macular Degeneration Lesions
Sponsor: Pfizer/ITEC GROUP 3
Information: http://www.clinicaltrials.gov/ct2/show/results/NCT00324116


Retinal Physician, Issue: January 2010