RP Cure Tracker

Trials / NCT07509229

9-cis Beta-Carotene-Rich Extract of Dunaliella Alga in Retinitis Pigmentosa Patients

Enrolling by invitation Phase 1 / Phase 2 Supplement / diet, Drug / neuroprotection

Sponsor
Sheba Medical Center
Treatment
9-cis beta-Carotene-rich extract of Dunaliella alga; Placebo Corn Oil
Gene
Not stated
Conditions
Retinitis Pigmentosa
Ages
18 Years to no upper limit
Enrollment
41 participants
Started
2026-07-26
Main results expected
2028-04-30
Results posted
Not yet
Record last updated
2026-07-27

What the study is testing

The goal of this clinical trial is to learn if a natural supplement called 9-cis beta-carotene (derived from the Dunaliella alga) can improve vision and retinal function in adults with Retinitis Pigmentosa. The study will also monitor the safety of the food supplement and how it affects levels of Vitamin A-related proteins in the blood. The main questions the study aims to answer are: (1) Does taking the supplement improve light sensitivity in the retina (measured by microperimetry)? (2) Does the supplement improve electrical responses in the eye (ERG) or other visual functions like contrast and color vision? (3) How do blood levels of beta-carotene and Vitamin A change during treatment? Researchers will use a crossover design. This means every participant will receive both the active supplement and a placebo (a "dummy" pill with corn oil) at different times during the study to compare the results. Participants will take two soft-gel capsules twice a day for 3 months, undergo a 6-month "washout" period where no study capsules are taken.Then they will take the opposite capsules (either the supplement or the placebo) for another 3 months. The participants will visit the clinic 4 times over the course of 12 months for eye exams, eye imaging (like OCT), and blood tests. Participants will also receive follow-up phone calls every 6 weeks to check on their progress and health.

Where it runs

Israel (1)

Open on ClinicalTrials.gov for contacts and eligibility