A Study to Compare rhuFab V2 With Verteporfin Photodynamic in Treating Subfoveal Neovascular Macular Degeneration
Macular Degeneration
About this trial
This is an interventional treatment trial for Macular Degeneration focused on measuring Neovascular age-related macular degeneration
Eligibility Criteria
Inclusion Criteria: Signed informed consent Age >=50 years Eligibility for treatment with PDT using verteporfin in the study eye according to the Visudyne product labeling Future treatment with PDT using verteporfin anticipated or expected in the study eye Primary or recurrent subfoveal choroidal neovascularization (CNV) lesions secondary to age-related macular degeneration (AMD) in the study eye A classic CNV component (well-demarcated hyperfluorescence boundaries in the early phase of the fluorescein angiogram) that is >=50% of the total lesion size Total lesion size of less than or equal to 5400 um in greatest linear dimension (GLD) Best corrected visual acuity, using Early Treatment of Diabetic Retinopathy Study (ETDRS) charts, of 20/40 to 20/320 (Snellen equivalent) in the study eye Exclusion Criteria: Prior treatment with verteporfin, external-beam radiation therapy, or transpupillary thermotherapy (TTT) in the study eye Treatment with verteporfin in the non-study eye less than 7 days preceding Day 0 Previous participation in a clinical trial (for either eye) involving anti angiogenic drugs (pegaptanib, ranibizumab, anecortave acetate, protein kinase C inhibitors, etc.) Previous intravitreal drug delivery (e.g., intravitreal corticosteroid injection or device implantation) 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 Day 0 History of vitrectomy surgery in the study eye History of submacular surgery or other surgical intervention for AMD in the study eye Previous participation in any studies of investigational drugs within 1 month preceding Day 0 (excluding vitamins and minerals) 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 lesion area or >=1 disc area (DA) 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 Retinal pigment epithelial tear involving the macula in the study eye Any concurrent intraocular condition in the study eye (e.g., cataract or diabetic retinopathy) that, in the opinion of the Investigator could either: (1) Require medical or surgical intervention during the 24-month study period to prevent or treat visual loss that might result from that condition, or (2) If allowed to progress untreated, could likely contribute to loss of at least 2 Snellen equivalent lines of best corrected visual acuity over the 24-month study period Active intraocular inflammation (grade trace or above) in the study eye Current vitreous hemorrhage in the study eye History of rhegmatogenous retinal detachment or macular hole (Stage 3 or 4) in the study eye History of idiopathic or autoimmune-associated uveitis in either eye Infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye Aphakia or absence of the posterior capsule in the study eye Spherical equivalent of the refractive error in the study eye demonstrating more than -8 diopters of myopia Intraocular surgery (including cataract surgery) in the study eye within 2 months preceding Day 0 Uncontrolled glaucoma in the study eye (defined as intraocular pressure >=30 mmHg despite treatment with anti-glaucoma medication) History of glaucoma filtering surgery in the study eye History of corneal transplant in the study eye Premenopausal women not using adequate contraception History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect interpretation of the results of the study or render the subject at high risk for treatment complications Current treatment for active systemic infection History of allergy to fluorescein, not amenable to treatment Inability to obtain fundus photographs or fluorescein angiograms of sufficient quality to be analyzed and graded by the central reading center Inability to comply with study or follow up procedures
Sites / Locations
- Retina Centers, P.C.
- University of Arizona
- Retina-Vitreous Associates Medical Group
- UC Irvine
- Doheny Eye Institute
- California Vitreoretinal Research Center
- No. California Retina-Vitreous Associates
- UCSF School of Medicine
- Danbury Eye Physicians & Surgeons
- New England Retina Associates
- Florida Retina Institute
- Retina Vitreous Consultants
- Retina Consultants of Southwest Florida
- Retina Health Center
- Retina Associates of South Florida
- Bascom Palmer Eye Institute
- Central Florida Retina
- Retina Care Specialists
- Bascom Palmer Eye Institute
- Ophthalmic Consultants
- Southern Vitreoretinal Associates PA
- University of South Florida
- Emory University
- Medical College of Georgia
- Thomas A. Ciulla, MD, PC
- University of Kansas Medical Center
- Retina Associates PC
- New England Eye Center
- Center for Eye Research
- New England Retina Consultants
- University of Michigan
- Associated Retinal Consultants
- Associated Retinal Consultants, P.C.
- Retina Consultants of Michigan
- Retina Associates of St. Louis
- St. Louis University Eye Institute
- Delaware Valley Retina Associates
- Lions Eye Institute
- Ophthalmic Consultants of Long Island
- Western Carolina Retinal Associates, PA
- Southeast Clinical Research
- Duke Univ Medical Center/Duke Eye Center
- Retina Associates of Cleveland
- Flavio Company
- Cleveland Clinic Foundation/Cole Eye Institute
- Midwest Retina
- Retina Vitreous Associates
- Retinal Associates of Oklahoma
- Retina & Vitreous Center of So. Oregon
- Pennsylvania Retina Specialists
- Wills Eye Hospital
- Allegheny General Hospital
- Retina Consultants of Charleston
- Palmetto Retina Center
- BH Regional Eye Institute
- Southeastern Retina Associates, P.C.
- Retina Vitreous Associates
- Austin Retina Associates
- Brian Berger, MD P.A.
- Retina Specialists
- UTMB
- Vitreoretinal Consultants
- Valley Retina Institute, P.A.
- Univ of Texas Health Science Center
- Medical Center Ophthalmology
- Rocky Mountain Retina Consultants
- John Moran Eye Center/Univ of Utah
- Retina Group of Washington
- Vitreoretinal Associates
- Medical College of Wisconsin
- University of Melbourne, Department of Ophthalmology
- Marsden Eye Research Pty Ltd
- Save Sight Institute
- Westmead Hospital
- Onci klinika FNKV
- Clinique d'Ophtalmologie
- Clinique Monticelli
- Hôpital Lariboisière
- Universitätsklinikum Bonn
- Universitatskliniken Koln
- Universitätsklinikum Leipzig
- Semmelweis University, 1st Ophthalmological Department