Lucentis for Age-related Macular Degeneration Pigment Epithelial Detachments (DETAIL)

Pacific Eye Associates

Status and phase: Completed; Phase 3; Phase 2

Conditions: Pigment Epithelial Detachment; Wet Macular Degeneration; Age-related Macular Degeneration; Neovascular Macular Degeneration

Treatments: Drug: ranibizumab

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00590694

DETAIL Study for PED in AMD

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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15 participants in 2 patient groups

Group1

Active Comparator group

Description:

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

Treatment:

Drug: ranibizumab

Group 2

Active Comparator group

Description:

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

Treatment:

Drug: ranibizumab