Lucentis for Age-related Macular Degeneration Pigment Epithelial Detachments
Overview
Patients with neovascular Age-related macular degeneration (AMD) and the particular feature of pigment epithelial detachments (PEDs) were not studied in the Phase III trials for ranibizumab (Lucentis). The PrONTO study was the first ranibizumab study to enroll such patients but only treated with ranibizumab until fluid within the layers of the retina was absent, not until the entire PED was absent. This study hypothesizes that there may be a difference in benefit between patients treated until just the retinal edema is gone and those in which the retinal edema and PED are both gone.
Full Title of Study: “Determining Optimal Treatment Algorithms for Macular Degeneration Pigment Epithelial Detachments Treated With Intraocular Lucentis”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: December 2009
Interventions
- Drug: ranibizumab
- 0.5mg injection monthly according to protocol for one year
Arms, Groups and Cohorts
- Active Comparator: Group1
- Will receive ranibizumab treatments until resolution of macular edema only and as macular edema recurs.
- Active Comparator: Group 2
- Will receive ranibizumab treatments until resolution of both macular edema and PED, and as macular edema or PED recur.
Clinical Trial Outcome Measures
Primary Measures
- Mean change in visual acuity from baseline over 12 months
- Time Frame: 12 months
Secondary Measures
- Time to OCT resolution of macular edema and pigment epithelial detachment
- Time Frame: One year
- Proportion of patients with complete resolution of PED at 6 and 12 months
- Time Frame: 12 months
- Durability of outcome: time from last ranibizumab injection to retreatment
- Time Frame: One year
Participating in This Clinical Trial
Inclusion Criteria
- Neovascular age-related macular degeneration patients over age 50 – Presence of a pigment epithelial detachment on optical coherence tomography – Initial or recurrent disease – Previous treatment allowed – Visual acuity between Snellen 20/40 – 20/400 Exclusion Criteria:
- More than three previous treatments with PDT or other radiation/laser therapy – Previous vitrectomy or other AMD surgical intervention – Severe scarring or severe concurrent ocular disease (uncontrolled glaucoma) Patients eligible for the study are randomized into one of two groups. Group 1 receives injections of ranibizumab until retinal edema is resolved. Group 2 receives ranibizumab injections until both retinal edema and the PED are resolved. Study duration is one year with visits once per month.
Gender Eligibility: All
Minimum Age: 50 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Pacific Eye Associates
- Collaborator
- Genentech, Inc.
- Provider of Information About this Clinical Study
- Sponsor
- Overall Official(s)
- Anne Fung, MD, Principal Investigator, Pacific Eye Associates / California Pacific Medical Center
References
Fung AE, Lalwani GA, Rosenfeld PJ, Dubovy SR, Michels S, Feuer WJ, Puliafito CA, Davis JL, Flynn HW Jr, Esquiabro M. An optical coherence tomography-guided, variable dosing regimen with intravitreal ranibizumab (Lucentis) for neovascular age-related macular degeneration. Am J Ophthalmol. 2007 Apr;143(4):566-83. doi: 10.1016/j.ajo.2007.01.028.
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