CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 271 enrolled
Drug / intervention
AGN-150998 +2 moredrug
Likely dose
ranibizumab 0.5 mgfrom 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/NCT01397409
NCT01397409Phase 2Completed
CompareCT.gov

Evaluation of AGN-150998 in Exudative Age-related Macular Degeneration (AMD)

Allergan·interventional·Posted Jul 19, 2011·Updated Apr 16, 2019

In Brief

A Phase 2 clinical trial evaluating AGN-150998, ranibizumab, and 1 other intervention for Age-related Macular Degeneration. Completed, enrolled 271 participants across 8 sites in 8 countries.

Detailed Summary

This study is conducted in 3 stages. Stage 1 is an open-label, dose-escalation assessment of the safety of AGN-150998 administered as a single intravitreal injection to patients with advanced exudative Age-related Macular Degeneration (AMD). Stage 2 and Stage 3 are randomized, double-masked, comparisons of the safety and treatment effects on retinal edema and best-corrected visual acuity (BCVA) of AGN-150998 and ranibizumab in treatment-naive patients with exudative AMD. Study medication is administered as needed in Stage 2 and with a fixed-dosing schedule in Stage 3. The study objectives are (1) to identify the highest tolerated dose of AGN-150998, (2) to assess the safety and duration of treatment effects on retinal edema and BCVA, and (3) to characterize the systemic pharmacokinetic profile of AGN-150998.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAge-related Macular Degeneration
CountriesAustralia, Austria, France, Germany, Israel, Italy, Switzerland, United States
Collaborators--

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJul 19, 2011
Enrollment StartSep 1, 2011
Primary CompletionMar 31, 2014
Study CompletionApr 30, 2014
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 15.0 years ago

Interventions

AGN-150998drug

AGN-150998 Intravitreal injection.

ranibizumabdrug

Ranibizumab 0.5 mg given by intravitreal injection.

Sham Injectionother

Stage 3: Sham injection at Weeks 12 and 16.