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Safety and Efficacy of Zuretinol Acetate in Subjects With Inherited Retinal Disease

NCT04311112 · Status: WITHDRAWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL

Last updated 2023-02-24

No results posted yet for this study

Summary

To evaluate the efficacy of ZA oral solution in subjects with IRD caused by biallelic recessive RPE65 or LRAT gene mutations and phenotypically diagnosed as Leber's Congenital Amaurosis (LCA) or Retinitis Pigmentosa (RP).

Conditions

  • Retinal Disorder

Interventions

DRUG

Placebos

Placebo

DRUG

ZA Low dose

ZA low dose

DRUG

ZA high dose

ZA high dose

Sponsors & Collaborators

  • Retinagenix Holdings

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-31
Primary Completion
2023-02-28
Completion
2023-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT04311112 on ClinicalTrials.gov