At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 24 enrolled
Drug / intervention
RN6G +1 morebiological
Likely dose
RN6G 5 mg/kgfrom 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.
A PHASE 1, DOUBLE-MASKED, PLACEBO-CONTROLLED STUDY EVALUATING THE SAFETY, TOLERABILITY, IMMUNOGENICITY, PHARMACOKINETICS AND PHARMACODYNAMICS OF MULTIPLE ESCALATING DOSAGES OF RN6G (PF-04382923) IN SUBJECTS WITH ADVANCED DRY, AGE-RELATED MACULAR DEGENERATION (AMD) INCLUDING GEOGRAPHIC ATROPHY
In Brief
A Phase 1 clinical trial evaluating RN6G and Placebo for Age-Related Maculopathy and 4 related conditions. Completed, enrolled 24 participants across 24 sites.
Detailed Summary
The purpose of this study is to determine the safety and tolerability of multiple doses of RN6G in subjects with advanced dry, age-related macular degeneration including geographic atrophy.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAge-Related Maculopathy, Age-Related Maculopathies, Eye Diseases, Retinal Degeneration, Macular Degeneration
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 2009
Enrollment StartAug 2010
Primary CompletionMar 2013
Study CompletionApr 2013
TodayJul 2026
First PostedOct 29, 2009
Enrollment StartAug 5, 2010
Primary CompletionMar 5, 2013
Study CompletionApr 19, 2013
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 16.7 years ago
Interventions
RN6Gbiological
Intravenous, multiple dose, dose ranging from 5 mg/kg up to a maximum of 15 mg/kg
Placebobiological
Intravenous, multiple dose with experimental dose