Trial | NCT00590694  Report issue

Title

Lucentis for Age-related Macular Degeneration Pigment Epithelial Detachments
Determining Optimal Treatment Algorithms for Macular Degeneration Pigment Epithelial Detachments Treated With Intraocular Lucentis

  • Phase

    Phase 2/Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    15
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 Started
Oct 31
2006
Primary Completion
Dec 31
2009
Study Completion
Dec 31
2009
Last Update
Apr 12
2012
Estimate

Drug ranibizumab

0.5mg injection monthly according to protocol for one year

  • Other names: Lucentis injection

Group1 Active Comparator

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

Group 2 Active Comparator

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

Criteria 

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.
No Results Posted