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Phase I/IIA Study of SAR422459 in Participants With Stargardt's Macular Degeneration

NCT01367444 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2022-04-14

Study results available
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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.

Conditions

  • Stargardt's Disease

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Paul Yang, MD · Oregon Health & Science University, Portland, Oregon

  • Jose-Alain Sahel, MD. Ph.D · Hopital Nationale des Quinze-Vingt, Paris France

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-08
Primary Completion
2019-08-16
Completion
2019-08-16
FDA Drug
Yes

Countries

  • United States
  • France

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01367444 on ClinicalTrials.gov