Lucentis for Age-related Macular Degeneration Pigment Epithelial Detachments

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

Study Completion Date

2009-12-31

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.

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group1

Will receive ranibizumab treatments until resolution of macular edema only and as macular edema recurs.

Group Type ACTIVE_COMPARATOR

ranibizumab

Intervention Type DRUG

0.5mg injection monthly according to protocol for one year

Group 2

Will receive ranibizumab treatments until resolution of both macular edema and PED, and as macular edema or PED recur.

Group Type ACTIVE_COMPARATOR

ranibizumab

Intervention Type DRUG

0.5mg injection monthly according to protocol for one year

Interventions

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ranibizumab

0.5mg injection monthly according to protocol for one year

Intervention Type DRUG

Other Intervention Names

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Lucentis injection

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.

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No