Trials / Terminated
TerminatedNCT01367444
Phase I/IIA Study of SAR422459 in Participants With Stargardt's Macular Degeneration
A Phase I/IIA Dose Escalation Safety Study of Subretinally Injected SAR422459, Administered to Patients With Stargardt's Macular Degeneration
- Status
- Terminated
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 27 (actual)
- Sponsor
- Sanofi · Industry
- Sex
- All
- Age
- 6 Years
- Healthy volunteers
- Not accepted
Summary
Primary Objective: To assess the safety and tolerability of ascending doses of SAR422459 in participants with Stargardt's Macular Degeneration (SMD). Secondary Objective: To evaluate for possible biological activity of SAR422459.
Detailed description
The total duration per participant was up to 52 weeks, which included 4 week screening period and 48 weeks study period. At the end of the study, the participants were invited to enter in an open-label safety study (LTS13588-NCT01736592) for long-term follow-up visits including ophthalmological examinations and recording of adverse events (AEs) for up to 15 years.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SAR422459 | Pharmaceutical form: sterile solution, 100 microliters (μL) aliquots in 0.3 milliliter (mL) type I borosilicate glass 'V' vials with a butyl stopper and aluminum crimp seal. Route of administration: subretinal injection |
Timeline
- Start date
- 2011-06-08
- Primary completion
- 2019-08-16
- Completion
- 2019-08-16
- First posted
- 2011-06-07
- Last updated
- 2022-04-14
- Results posted
- 2020-06-05
Locations
5 sites across 2 countries: United States, France
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT01367444. Inclusion in this directory is not an endorsement.