Lucentis for Age-related Macular Degeneration Pigment Epithelial Detachments

Phase 2

Completed

• Conditions: Age-related Macular Degeneration; Pigment Epithelial Detachment; Neovascular Macular Degeneration; Wet Macular Degeneration
• Interventions: Drug: ranibizumab

• Registration Number: NCT00590694
• Lead Sponsor: Pacific Eye Associates

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-10
• Study First Submitted: 2007-12-26
• Study First Submitted QC: 2008-01-10
• Study First Posted: 2008-01-11
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-10
• Last Update Posted: 2012-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2	ranibizumab	Will receive ranibizumab treatments until resolution of both macular edema and PED, and as macular edema or PED recur.
Group1	ranibizumab	Will receive ranibizumab treatments until resolution of macular edema only and as macular edema recurs.

Primary Outcome Measures

Name	Time	Method
Mean change in visual acuity from baseline over 12 months	12 months

Secondary Outcome Measures

Name	Time	Method
Durability of outcome: time from last ranibizumab injection to retreatment	One year
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

Trial Locations

Locations (1)

Pacific Eye Associates; 🇺🇸 San Francisco, California, United States