Article Date: 11/1/2009

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 intravitreal (ITV) drug delivery; intraocular surgery (including cataract surgery) in the study eye within three months preceding Day 0; previous participation in any studies of investigational drugs within one 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 Photobiomodulation Study for Dry Age Related Macular Degeneration
Sponsor: Graham Merry, MD
Purpose: To evaluate clinical outcomes of Photobiomodulation 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
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: GATE: Geographic Atrophy Treatment Evaluation
Sponsor: Alcon Research
Purpose: To evaluate AL-8309B as a topical ocular treatment for geographic atrophy secondary to AMD
Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment
Number of Patients: 550
Inclusion Criteria: Patient must state the ability to administer eye drops or have a caretaker to administer the eye drops; well-demarcated area of atrophy secondary to AMD if the lesion is multifocal
Exclusion Criteria: Ocular disease in the study eye that in the opinion of the Investigator may confound assessment of the retina or affect central vision, other than non-exudative AMD
Information: medical.information@alconlabs.com

► 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 one 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 >0.5 and <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: Safety and Tolerability of ACU-4429 in Healthy Volunteers for Potential Therapy for Dry Age-related Macular Degeneration
Sponsor: Acúcela, Inc.
Information: www.acucela.com

WET AMD

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 Criteria: 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 intravitreally 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 Corporation
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 neovascularization (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: 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
Purpose: To evaluate the safety and feasibility of focal delivery of radiation for the treatment of subfoveal CNV in patients with AMD that have failed primary anti-VEGF therapy
Design: Treatment, Nonrandomized, Open-label, Uncontrolled, Single-group Assignment, Safety/Efficacy Study
Number of Patients: 20
Inclusion Criteria: Subjects must have predominantly classic, minimally classic, or occult with no classic lesions, as determined by the Investigator, secondary to AMD, with a total lesion size (including blood, scarring, and neovascularization) of <12 total disc areas (21.24 mm2), and a GLD ≥5.4 mm; subjects must have received a minimum of three prior injections of anti-VEGF therapy with evidence of "failure" to respond to therapy; subjects must be age 50 or older
Exclusion Criteria: Subjects with prior or subfoveal CNV therapy with photodynamic therapy, intravitreal or subretinal steroids, or transpupillary thermotherapy (TTT) (Note: This includes subjects with no known history, but with photographic evidence of prior therapy); subjects who underwent previous radiation therapy to the eye, head or neck
Information: clinicaltrials@neovistainc.com

► 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 two 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 three 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 20/40O; 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 peri-ocular infection; ocular surgery within one month prior to the study
Information: vu@retinadocs.com

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

► Study: A Phase 1 Safety Study of Single and Repeated Doses of JSM6427 (Inlravilreal 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 Pegylaled Aplamer) in Subjects With Neovascular Age-Related Macular Degeneration
Sponsor: Ophthotech Corp.
Information: denise.teuber@ophthotech.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: The MAP Study: FA/Medidur for AMD Pilot
Sponsor: Johns Hopkins University/Alimera Sciences
Information: ghafizl@jhmi.edu

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

► Study: High Speed Indocyanine Green Angiography Findings in Ranibizumab Treatment for Wet Age-Relaled 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

► 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

DIABETIC MACULAR EDEMA

► 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 aser photocoagulation or has been refractory to laser photocoagulation; participant must have a negative PPD skin test; participant must understand and sign the protocol'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 ocular surgery or an intravitreal/periocular steroid injection in the study eye within the past 3 months; participant has had a YÀG laser capsulotomy or intravitreal anti-VEGF treatment in the study eye within the past six weeks
Information: roje-oktay.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 alternative or adjunctive treatment to laser photocoagulation, 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 three-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 glycémie control who, within the last four months, initiated intensive insulin treatment (a pump or multiple daily injections) or plan to do so in the next four 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, centra retinal 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 l 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 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) 533-550

► 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: 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 Criteria: 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 three 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 Universíty/Bausch & Lomb, Inc.
Purpose: To determine whether a fluocinolone sustained drug delivery implant is effective ín 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 OcclusionTo determine whether niacin
Sponsor: Palmetto Retina Center, LLC; Pfizer; OSI Pharmaceuticals
Status: Currently enrolling
Purpose: Study is to evaluate the effect of intravitreal injections of Macugen every six 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 significant cataract, diabetic retinopathy, AMD, glaucoma, uveitis, epiretinal membrane, vitreomacular traction or tumor; intraocular surgery within past3 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 ín 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
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. A central retinal vein occlusion (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

OTHER

Study: BEAT-ROP: Bevacizumab Eliminates the Angiogenic Threat of Retinopathy of Prematurity
Sponsor: The University of Texas Health Science Center, Houston
Purpose: To determine whether injections into the vitreous of an anti-vascular endothelial growth factor (VEGF) will reduce the incidence of blindness by suppressing the neovascular phase of retinopathy of prematurity (ROP) compared to a control group receiving conventional laser therapy
Design: Treatment, Randomized, Open-label, Active Control, Parallel Assignment, Safety/Efficacy Study
Number of Patients: 150
Inclusion Criteria: Infants who have been screened by the AAO, AAP, and the AAPOS guidelines (≤1500 grams at birth and ≤30 weeks gestation) who develop Stage 3 ROP in zone I or posterior zone II
Exclusion Criteria: Infants who have a congenital systemic anomaly or have a congenital ocular abnormality; infants who cannot be treated by conventional laser therapy because of problems with media clarity
Information: Helen.A.Mintz-Hittner@uth.tmc.edu

Study: BLOCK-ROP: Pan-VEGF Blockade for the Treatment of Retinopathy of Prematurity
Sponsor: Vision Research Foundation
Purpose: To evaluate bevacizumab for safety and efficacy in treatment of retinopathy of prematurity
Design: Treatment, Open-label, Single Group Assignment, Safety Study
Number of Patients: 22
Inclusion Criteria: Premature newborn infants with bilateral progressive APROP despite complete peripheral retinal ablation; inborn babies at participating NICUs; outborn babies transferred to participating NICU
Exclusion Criteria: Fatal systemic anomaly; an ocular anomaly of one or both eyes affecting the retina or choroid; an ocular anomaly precluding use of the RetCam
Information: (248) 288-2280

Study: Safety Study of Ranibizumab Eye Injections to Treat Choroidal Neovascularization That Was Caused Other Than by Age-Related Macular Degeneration
Sponsor: Ophthalmic Consultants of Boston/Genentech
Information: jbankert@eyeboston.com

COMPLETED ENROLLMENT

► Study: Safety Study of iSONEP (Sonepcizumab/LT1009) to Treat Neovascular Age-Related Macular Degeneration
Sponsor: Lpath, Inc.
Information: (270) 554-8929

Study: Safety Study of iCo-007 Intravitreal Injection to Treat Diabetic Macular Edema
Sponsor: iCo Therapeutics Inc.
Information: nidia.rosado@duke.edu

Study: Laser-Ranibizumab-Triamcinolone for Proliferative Diabetic Retinopathy
Sponsor: NEI/Genentech/Allergan
Information: (866) 372-7601

► Study: Randomized, Double Blind Trial of Bromfenac BID (0.09%) as an Adjunct to Argon Laser Therapy in the Treatment of DME
Sponsor: Bp Consulting, Inc.
Information: michelle-bpconsulting@yahoo.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



Retinal Physician, Issue: November 2009