Article Date: 6/1/2010

Clinical Trials Update

Clinical Trials Update

DRY AMD

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
Information: (865) 483-6399

Study: Sirolimus to Treat Geographic Atrophy Associated With Age-Related Macular Degeneration
Sponsor: National Eye Institute
Information: (800) 411-1222

Study: A Multi-Center Study of Reading Rehabilitation in Macular Disease
Sponsor: Department of Veterans Affairs
Information: pdgrant@uic.edu

Study: Safety And Tolerability Study Of RN6G In Patients With Dry, Age-Related Macular Degeneration
Sponsor: Pfizer
Information: (800) 718-1021

Study: Fluocinolone Acentonide Intravitreal Inserts in Geographic Atrophy
Sponsor: Alimera Sciences
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@rvrc.com

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: LAST: A Pilot Study to evaLuate the Role of High-dose rAnbizumab (2.0mg) in the Management of AMD in Patients With perSistent/recurrenT Macular Fluid Less Than 30 Days Following Treatment With Intravitreal Anti-VEGF Therapy
Sponsor: Vitreous-Retina-Macula Consultants of New York
Purpose: To compare intravitreally administered 0.5 mg ranibizumab to 2.0 mg ranibizumab in subjects who manifest persistent or recurrent macular fluid less than 30 days following treatment with intravitreal anti-VEGF therapy
Design: Interventional, Randomized, Efficacy Study, Parallel-assignment, Single-blind, Treat ment
Number of Patients: 30
Inclusion Criteria:Subfoveal neovascularization secondary to AMD; best corrected visual acuity in the study eye between 20/30 to 20/400 using an ETDRS chart; documentation of the presence of subretinal fluid and/or cystoid macular edema on SD-OCT less than 30 days following at least six months of anti-VEGF therapy; presence of fibrosis, hemorrhage, or other hypofluorescent lesions should not obscure greater than 50% of the CNV lesion
Exclusion Criteria: Prior treatment with anti- VEGF therapy in the study eye within 30 days of BSL; prior treatment with triamcinolone in the study eye within six months of BSL; prior treatment with dexamethasone in the study eye within 30 days prior to BSL; past treatment with PDT or thermal laser in the study eye; intraocular surgery (including cataract surgery) in the study eye within two months preceding BSL; history of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD in the study eye; active intraocular inflammation (grade trace or above) in the study eye; current vitreous hemorrhage in the study eye
Information: pguerrero@vrmny.com

Study: A Prospective Study Comparing Ranibizumab Plus Dexamethasone Combination Therapy Versus Ranibizumab Monotherapy for Wet AMD (Lucedex)
Sponsor: Bay Area Retina Associates
Purpose: To evaluate the safety of intravitreal ranibizumab in combination with intravitreal dexamethasone in comparison to intravitreal ranibizumab alone in the treatment of wet ARMD
Design: Randomized, Safety, Parallel-assignment, Single-blind, Supportive-care
Number of Patients: 40
Inclusion Criteria: All lesion subtypes will be enrolled with the following criteria Predominantly and minimally classic: angiographic lesion greater than 50% of the total lesion area; occult: lesions must show recent activity progression with respect to vision, subretinal hemorrhage or subretinal fluid
Exclusion Criteria: Previous treatment for AMD in the study eye; previous intravitreal drug delivery in the study eye; previous vitrectomy in the study eye; fibrosis or atrophy involving the center of the fovea in the study eye; neovascular membrane from any other concurrent retinal disease such as high myopia (SER > −8D), histoplasmosis or other ocular inflammatory disease; known history of glaucoma and on more than one topical medication; history of glaucoma filtering surgery in the study eye; history of corneal transplant in the study eye
Information: lsray01@yahoo.com

Study: A Safety and Efficacy Study of E10030 (Anti-PDGF Pegylated Aptamer) Plus Lucentis for Neovascular Age-Related Macular Degeneration
Sponsor: Ophthotech Corporation
Purpose: To evaluate the safety and efficacy of E10030 intravitreous injection when administered in combination with Lucentis against a control of Lucentis alone in subjects with subfoveal choroidal neovascularization secondary to age-related macular degeneration (AMD)
Design: Randomized, Active Control, Safety/Efficacy Study, Parallel Assignment, Double-blind, Treatment
Number of Patients: 444
Inclusion Criteria: Subfoveal choroidal neovascularization (CNV) due to AMD
Exclusion Criteria: Diabetes mellitus; History or evidence of severe cardiac disease (eg, NYHA Functional Class III or IV, history or clinical evidence of unstable angina, acute coronary syndrome, myocardial infarction or coronary artery revascularization within six months, or ventricular tachyarrhythmias requiring ongoing treatment; clinically significant impaired renal or hepatic function; stroke (within 12 months of trial entry); any major surgical procedure within one month of trial entry; known serious allergies to the fluorescein dye used in angiography (mild allergy amenable to treatment is allowable), to the components of the ranibizumab (Lucentis) formulation, or to the components of the E10030 formulation
Information: (919) 456-5103

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, Nonrandomized, Openlabel, 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; adequate dilation of pupils to permit thorough ocular examination and testing
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
Information: medinfo@genzyme.com

Study: A Study of Intravitreal Injections of 2.0 mg Ranibizumab in Subjects With Chronic Fluid On OCT Post Multiple Injections With Ranibizumab (Superdose 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; best corrected visual acuity 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 safe 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; best corrected visual acuity score in the fellow eye of 20/400 or better at the Screening Visit; only one eye will be treated (study eye) through the duration of the study. In the event both eyes are eligible for study entry the study eye should be selected by the investigator and subject; the non-study eye may be treated with approved AMD therapy
Exclusion Critieria: Prior treatment with verteporfin photodynamic therapy, externalbeam 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 one month preceding baseline; history of vitrectomy, submacular surgery or other surgical intervention for AMD 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
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
Information: (800) 718-1021

Study: Retinal and Retinal Pigment Epithelium (RPE) Autoimmunity in Age-related Macular Degeneration (AMD) — Correlation With Lucentis 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 four 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
Information: dgtelander@ucdavis.edu

Study: A Study of Ranibizumab Adminis tered 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 transpupillary therapy 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.
Information: (212) 845-8214

Study: Detection of Neutralizing Antibodies in Patients Treated With Bevacizumab or Ranibizumab
Sponsor: National Eye Institute
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
Information: lillian.rmi@gmail.com

Study: ERG/EOG Study in AMD Patients Treated With Ranibizumab
Sponsor: Retina Center, Minnesota/Genentech
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: 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: 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: 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: 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: Pilot Study for the Evaluation of Minocycline as a Microglia Inhibitor in the Treatment of Diabetic Macular Edema
Sponsor: National Eye Institute
Purpose: To test the safety and effectiveness of minocycline as a treatment for diabetic macular edema
Design: Nonrandomized, Uncontrolled, Safety/Efficacy Study, Single-group Assignment, Open-label, Treatment
Number of Patients: 8
Inclusion Criteria: Best-corrected ETDRS visual acuity score between 78 and 39 letters (ie, between 20/32 and 20/200); definite retinal thickening due to diabetic macular edema based on clinical exam involving the center of the macula that is not refractory to further therapy as based on the investigator's clinical judgment; previous treatment with focal laser photocoagulation following standard-ofcare/ best practice guidelines, as described by the ETDRS study, greater than or equal to three months prior to enrollment unless the edema is not responsive to previous laser and/or not amenable to safe laser treatment at the discretion of the investigator. The laser treatment may be performed at the NEI clinical center or by an outside ophthalmologist at the discretion of the participant and the investigator
Exclusion Criteria: An eye should not be considered eligible if: The macular edema is considered to be related to cataract extraction or clinical exam and/or OCT suggest that vitreoretinal interface disease (eg, a taut posterior hyaloid or epiretinal membrane) is the primary cause of the macular edema
Information: prpl@mail.cc.nih.gov

Study: READ 3: Ranibizumab for Edema of the mAcula in Diabetes: Protocol 3 With High Dose
Sponsor: Johns Hopkins University/Juvenile Diabetes Research Foundation
Purpose: To investigate the safety, tolerability, bioactivity, and dose response of two different dosages (0.5 mg and 2.0 mg) of ranibizumab (RBZ) in patients with diabetic macular edema
Design: Treatment, Randomized, Single Blind (Subject), Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Number of Patients: 92
Inclusion Criteria: Diagnosis of diabetes mellitus (type 1 or type 2); serum HbA1c ≥5.5% within 12 months of randomization. Retinal thickening secondary to diabetes mellitus (diabetic macular edema) involving the center of the fovea; diagnosis must be confirmed by fluorescein angiography and OCT images; foveal thickness of ≥250 μm; best corrected visual acuity score in the study eye of 20/40 to 20/320 inclusive (Snellen equivalents using the ETDRS protocol at a distance of 4 meters); the non-study eye must be ≥20 letters (approximate Snellen equivalent 20/400); in the opinion of the investigator, decreased vision in the study eye is due to foveal thickening from DME and not from other obvious causes of decreased vision
Exclusion Criteria: Panretinal photocoagu lation or macular photocoagulation within 3 months of study entry in the study eye; use of intraocular or periocular injection of steroids in the study eye (eg, triamcinolone) within three months of study entry; previous participation in a study and receipt of anti-angiogenic drugs (pegaptanib sodium, ranibizumab, bevacizumab, anecortave acetate, protein kinase C inhibitor, etc.) within two months of study entry; proliferative diabetic retinopathy in the study eye, with the exceptions of inactive, fibrotic proliferative diabetic retinopathy that has regressed following panretinal laser photocoagulation ortufts of NVE less than one disc area with no vitreous hemorrhage
Information: jdenton2@jhmi.edu

Study: Efficacy of Aliskiren in the Treatment of Diabetic Macular Edema
Sponsor: Novartis Pharmaceuticals
Purpose: To assess the efficacy of oral aliskiren (Tekturna) as a therapy for diabetic macular edema
Design: Treatment, Randomized, Double-blind (Subject, Caregiver, Investigator), Parallel Assignment
Number of Patients: 110
Exclusion Criteria: Recent intraocular surgery in the study eye (eg, cataract surgery in the last six months); recent laser photocoagulation in the study eye; recent treatment with Avastin, Lucentis, or intra vitreal corticosteroids in the study eye
Information: (862) 778-8300

Study: Study of MP0112 Intravitreal Injection in Patients With Diabetic Macula Edema
Sponsor: Molecular Partners AG
Purpose: To assess the safety and tolerability of MP0112 (a novel, potentially long acting VEGF inhibitor) in patients with diabetic retinal edema
Design: Treatment, Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Number of Patients: 36
Inclusion Criteria: Macular edema due to diabetic retinopathy; best-corrected visual acuity in the study eye of 20/40 to 20/400; central subfield thickness ≥250 μm by OCT
Exclusion Criteria: Any indication of irreversible vision loss such as significant atrophy, scarring, fibrosis, or hyper-pigmentation in the fovea; presence of significant ocular abnormalities in the study eye that prevent retinal assessment, including media opacities, cataract, or inadequate papillary dilation
Information: info@molecularpartners.com

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
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

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
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
Information: roje-oktay.kacmaz@mssm.edu

Study: Near-Infrared Light (NIR) Therapy for Diabetic Macular Edema: A Pilot Study
Sponsor: Medical College of Wisconsin
Information: hwhelan@mcw.edu

Study: Safety and Efficacy of a New Treatment in Vitrectomized Subjects With Diabetic Macular Edema
Sponsor: Allergan
Information: clinicaltrials@allergan.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) 533-6550

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: Single Site, Masked, Randomized, Controlled Study to Assess Efficacy of Osurdex as Adjunct to Avastin Compared With Avastin Alone in the Treatment of Patients With Macular Edema Due to Central or Branch Retinal Vein Occlusion
Sponsor: Raj K. Maturi, MD, PC
Purpose: To see if treating with Ozurdex in addition to Avastin in patients with retinal vein occlusions helps increased visual acuity outcomes
Design: Treatment, Randomized, Single Blind (Subject), Parallel Assignment, Efficacy Study
Number of Patients: 40
Inclusion Criteria: Branch retinal vein occlusion or central retinal vein occlusion of less than one year duration; best correct visual acuity of greater than 24 and less than 80; presence of macular edema defined as OCT central subfield thickness of >250
Exclusion Criteria: Intravitreal anti-VEGF treatment in study eye within six weeks of baseline; intravitreal steroid treatment in the study eye within eight weeks of baseline visit; PRP in the study eye within four months of baseline visit; active iris neovascularization in study eye; uncontrolled systemic disease; known history of IOP elevation in response to corticosteroid treatment that is not controlled on two glaucoma medications
Information: eyeresearch2000@yahoo.com

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, Nonrandomized, 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
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
Information: retina@retina-assoc.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
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
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
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
Sponsor: 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;
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
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
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
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
Information: (212) 452-6965

UVEITIS

Study: ENDURE: Safety and Efficacy of AIN457 in Patients With Quiescent Non-infectious Uveitis
Sponsor: Novartis
Purpose: To assess the safety and efficacy of AIN457 as adjunctive therapy for the treatment of intermediate uveitis, posterior uveitis, or panuveitis requiring systemic immunosuppression
Design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment
Number of Patients: 232
Inclusion Criteria: Patients with quiescent chronic, non-infectious intermediate uveitis, posterior uveitis or panuveitis as evidenced by < 1+ anterior chamber cell grade and < 1+ vitreous haze in both eyes for at least 6 weeks prior to screening
Exclusion Criteria: Patients with a primary diagnosis of Behçet's disease, anterior uveitis or any intermediate uveitis, posterior uveitis or panuveitis in which the manifestation(s) of the active intraocular inflammatory disease may spontaneously resolve or that are not characterized by the presence of either anterior chamber cells or vitritis
Information: (862) 778-8300

Study: Pilot Study for the Evaluation of Intravitreal Infliximab in the Treatment of Uveitic 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 uveitis
Design: Uncontrolled, Efficacy Study, Single Group Assignment, Open Label, Treatment
Number of Patients: 10
Inclusion Criteria: 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 uveitic macular edema (as defined above) in both eyes; participant has multiple sclerosis or symptoms suggestive of multiple sclerosis; participant has evidence of ocular disease other than uveitis in either eye that may confound the outcome of the study (eg, diabetic retinopathy, age-related macular degeneration, vitreomacular traction, moderate/severe myopia, etc.
Information: farzin.forooghian@mssm.edu

Study: Apremilast in the Treatment of Uveitis
Sponsor: Oregon Health and Science University
Purpose: To assess the safety and efficacy of Apremilast in the treatment of uveitis
Design: Active Control, Safety/Efficacy Study, Single Group Assignment, Open Label, Treatment
Number of Patients: 5
Inclusion Criteria: Patients with vision-threatening autoimmune uveitis; failure to respond to prednisone and at least one other systemic immunosuppressive, or intolerance to such medications due to side effects
Exclusion Criteria: Serious concomitant illness that could interfere with the subject's participation; previous or current use of an alkylating agent; use of CYP3A4 in hibitors during the trial; TNF blocker use within the 8 weeks prior to enrollment
Information: suhlere@ohsu.edu

Study: SAVE: Sirolimus as Therapeutic Approach to Uveitis
Sponsor: John Hopkins University/MacuSight, Inc.
Purpose: To find out about the safety and effectiveness of the study drug, sirolimus, in patients with uveitis and to utilize the potential effectiveness of sirolimus, and yet to avoid the potential complications of systemic use of the drug
Design: Randomized, Safety/Efficacy Study, Parallel Assignment, Open-label, Treatment
Number of Patients: 30
Inclusion Criteria: Have posterior, intermediate, or panuveitis; for panuveitis, if an anterior component is present, it must be less than the posterior component
Exclusion Criteria: Intraocular surgery within 90 days prior to Day 0 in the study eye; capsulotomy within 30 days prior to Day 0 in the study eye; if the patient has had glaucoma surgery
Information: qnguyen4@jhmi.edu

Study: Uveitis in Relation to Perceived Stress: A Prospective Study
Sponsor: The New York Eye & Ear Infirmary
Purpose: To conduct a prospective analysis to determine the relationship between disease activity of noninfectious uveitis and stress
Design: Cohort, Prospective
Number of Patients: 200
Inclusion Criteria: Able to self-administer the Perceived Stress Scale
Exclusion Criteria: Diagnosis of infection uveities
Information: ktai@nyee.edu

Study: The Treatment of Uveitic Cystoid Macular Edema With Topical Interferon Gamma
Sponsor: National Eye Institute
Purpose: To investigate the safety and effectiveness of treating uveitis-associated macular edema with interferon gamma-1b
Design: Non-Randomized, Uncontrolled, Safety/Efficacy Study, Single Group Assignment, Open Label, Treatment
Number of Patients: 7
Inclusion Criteria: Participant has a diagnosis of intermediate, panuveitis or posterior uveitis at least three months prior to study enrollment and has associated CME secondary to uveitis in at least one eye
Exclusion Criteria: Participant had herpes keratitis in the past; participant is diagnosed with multiple sclerosis; participant has a significant active infection (an infection requiring treatment as determined by the medical team)
Information: prpl@mail.cc.nih.gov

Study: Pegaptanib Therapy in Uveitis
Sponsor: Wake Forest University
Purpose: To meet the need for considering alternative forms of local (ocular) therapy for CME to triamcinolone
Design: Inteventional, Uncontrolled, Efficacy Study, Single-group Assignment, Open-label, Treatment
Number of Patients: 5
Inclusion Criteria: Patients may be receiving systemic therapy for the treatment of their intraocular inflammation or cystoid macular edema, or may have been treated for the cystoid macular edema in the past
Exclusion Criteria: Allergy to pegaptanib or any of its components; diabetic retinopathy, macular degeneration or any other ocular condition affecting the study eye that may cause vision loss
Information: lcooke@wfubmc.edu

Study: Uveitis Gene-expression Profiling
Sponsor: Oregon Health and Science University
Purpose: To determine if patients with uveitis and ankylosing spondylitis, sarcoidosis, or Behçet's can be distinguished from a normal population or controls with the same systemic disease but no history of uveitis
Design: Observational, Case Control, Prospective
Number of Patients: 392
Inclusion Criteria: The study group will include patients aged 21 years or older attending the Uveitis Clinic at the Casey Eye Institute at OHSU who have uveitis of the following subtypes
Information: rosenbaj@ohsu.edu

Study: Multi Center Prospective Registry of Infliximab Use for Childhood Uveitis
Sponsor: Duke University/Childhood Arthritis and Rheumatology Research Alliance
Information: (919) 684-6575

Study: Pilot Study of Ranibizumab (Lucentis) for Uveitic Cystoid Macular Edema
Sponsor: University of Miami/Genentech
Information: talbini@med.miami.edu

Study: Immune Responses to Antigens in Noninfectious Eye Inflammatory Diseases
Sponsor: National Eye Institute
Information: (800) 411-1222

Study: Quality of Life and Visual Function in Uveitis Patients
Sponsor: New York Eye and Ear Infirmar
Information: (212) 979-4251

Study: Safety, Tolerability, and Efficacy of AEB071 in the Treatment of Uveitis
Sponsor: Novartis
Information: (862) 778-8300

Study: The Vitreous Proteome and Inflammatory Mediators in Ocular Inflammatory Disease
Sponsor: National Eye Institute
Information: prpl@mail.cc.nih.gov

Study: Epigenetics, Molecular Genetics, and Biomarkers of Degenerative and Inflammatory Retinal Diseases
Sponsor: National Eye Institute
Information: prpl@mail.cc.nih.gov

Study: LIME: Lucentis for Inflammatory Macular Edema Trial
Sponsor: University of California, San Francisco/Genentech
Information: kevin.hong@ucsf.edu

COMPLETED ENROLLMENT

Study: A Study of the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Intravitreal Injections of FCFD4514S in Patients With Geographic Atrophy
Sponsor: Genentech
Information: rossignol.natalie@gene.com

Study: A Clinical Safety and Efficacy Comparison of NEVANAC 0.1% to Vehicle After Cataract Surgery in Diabetic Retinopathy Patients
Sponsor: Alcon Research
Information: (888) 451-3937

Study: Adalimumab (Humira) in the Treatment of Refractory Non-Infectious Uveitis
Sponsor: Oregon Health and Science University
Information: suhlere@ohsu.edu

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



Retinal Physician, Issue: June 2010