Lucentis for Age-related Macular Degeneration Pigment Epithelial Detachments

Study Overview
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Brief Summary
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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.

Official Title
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Determining Optimal Treatment Algorithms for Macular Degeneration Pigment Epithelial Detachments Treated With Intraocular Lucentis

Conditions
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Age-related Macular Degeneration, Pigment Epithelial Detachment, Neovascular Macular Degeneration, Wet Macular Degeneration

Intervention / Treatment
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* Drug: ranibizumab


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group1<br>Will receive ranibizumab treatments until resolution of macular edema only and as macular edema recurs. | Drug: ranibizumab<br>* 0.5mg injection monthly according to protocol for one year<br>* Other names: Lucentis injection;|
| Active Comparator: Group 2<br>Will receive ranibizumab treatments until resolution of both macular edema and PED, and as macular edema or PED recur. | Drug: ranibizumab<br>* 0.5mg injection monthly according to protocol for one year<br>* Other names: Lucentis injection;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change in visual acuity from baseline over 12 months |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to OCT resolution of macular edema and pigment epithelial detachment |  | One year | 
| Proportion of patients with complete resolution of PED at 6 and 12 months |  | 12 months | 
| Durability of outcome: time from last ranibizumab injection to retreatment |  | One year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ranibizumab, Lucentis, Pigment Epithelial Detachment, Macular Degeneration, PrONTO