At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 8 enrolled
Drug / intervention
ADX-2191 +1 moredrug
Likely dose
ADX-2191 400 µg in 0.05 mL, intravitreal injection, monthly for 3 or 6 injectionsAI-extracted
Key inclusion· 3
- ✓Age 18 or older
- ✓Diagnosis of retinitis pigmentosa due to rhodopsin gene mutation
- ✓Visual field impairment confirmed by perimetry
Key exclusion· 3
- ✕Age less than 18 years
- ✕Pregnant or nursing women
- ✕Previous inflammatory or infectious eye events
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-label, Phase II Study of ADX-2191 in Subjects With Retinitis Pigmentosa
In Brief
A Phase 2 clinical trial evaluating ADX-2191 for Retinitis Pigmentosa. Completed, enrolled 8 participants across 1 site.
Detailed Summary
An open-label Phase II clinical trial, 8 (eight) subjects with retinitis pigmentosa due to rhodopsin mutations (including P23H) will be identified and treated with serial intravitreal injections of ADX-2191 in the worse seeing eye. Ocular structure and function will be evaluated.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRetinitis Pigmentosa
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
2023202420252026
First PostedMay 2022
Enrollment StartJul 2022
Primary CompletionJun 2023
TodayJul 2026
First PostedMay 26, 2022
Enrollment StartJul 14, 2022
Primary CompletionJun 23, 2023
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 4.1 years ago
Interventions
ADX-2191drug
Monthly intravitreal injections of ADX-2191 (400 µg in 0.05 mL) for a total of three injections. Evaluation through week 16.
ADX-2191drug
Monthly intravitreal injections of ADX-2191 (400 µg in 0.05 mL) for a total of six injections. Evaluation through week 16.