CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 20 enrolled
Drug / intervention
ranibizumabdrug
Likely dose
ranibizumab 0.5mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00896779
NCT00896779Phase 2Completed

Lucentis in Advanced Macular Degeneration

Steven R. Sanislo·interventional·Posted May 12, 2009·Updated Jun 29, 2015

In Brief

A Phase 2 clinical trial evaluating ranibizumab for Macular Degeneration. Completed, enrolled 20 participants across 2 sites.

Detailed Summary

Patients with low vision (visual acuity 20/400 or worse) were excluded from the large Phase III ranibizumab clinical trials. It is not known if treatment with ranibizumab results in improved visual function in such patients.Since ranibizumab has been shown to be the most effective therapy for exudative macular degeneration we propose to treat all patients in this study with monthly ranibizumab intravitreal injections. Patients will be assigned to one of two groups by the flip of a coin. Group #1 for "heads" and Group #2 for "tails". Group #1 patients will be treated for 3 monthly injections of 0.5 mg of ranibizumab and then as needed therapy. Group #2 will be treated with 6 monthly injections of 0.5 mg of ranibizumab and then as needed therapy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMay 12, 2009
Enrollment StartOct 1, 2009
Primary CompletionSep 1, 2013
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 17.1 years ago

Interventions

ranibizumabdrug

Group 1 - 0.5mg intravitreal injection every month for 3 months then as needed for 12 months Group 2 -0.5mg intravitreal injection every month for 6 months then as needed for 12 months