Lucentis for Age-related Macular Degeneration Pigment Epithelial Detachments

Pacific Eye Associates15 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Mean change in visual acuity from baseline over 12 months

Time frame: 12 months

Secondary Outcomes

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