Choroideremia Gene Therapy Clinical Trial

Completed · Phase 2

Conditions studied: Choroideremia

In brief

Phase II gene therapy study, involving a total of 6 male patients with choroideremia. The study will be conducted at the Bascom Palmer Eye Institute, University of Miami. Patients will be required to attend a total of 11 study visits over a 24 month period with an additional 3 year follow-up.

Key facts

Study ID

NCT02553135

Run by

Byron Lam

People needed

6

Starts

2015-09-01

Expected to finish

2018-02-01

Last updated by the study team

2019-07-29

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 18 Years and older
• Male
• Able to give informed consent
• Genetically confirmed diagnosis of choroideremia
• Active disease visible clinically within the macula region
• Best-corrected visual acuity equal to or worse than 20/32 but better than or equal to 20/200 in the study eye.

You may not qualify if…

• Female
• Under the age of 18
• History of amblyopia in the study eye
• Men unwilling to use barrier contraception methods
• Relevant grossly asymmetrical disease or other ocular morbidity which might confound use of the fellow eye as a long-term control
• Any other significant ocular and non-ocular disease/disorder or retinal surgery
• Contraindication to use of medications or contrast agents
• Participated in research study involving an investigational product in the past 12 weeks
• Having had gene or cellular therapy at any time prior to this study.

Where it is running

• Bascom Palmer Eye Institute, University of Miami — Miami, Florida, United States

Full record on ClinicalTrials.gov

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