NCT07509229

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

Not yet recruiting Phase 1, PHASE2 Last updated 3 April 2026

What this trial tests

Phase 1, PHASE2 trial testing 9-cis beta-Carotene-rich extract of Dunaliella alga in Retinitis Pigmentosa in 41 participants. Not yet recruiting.

Timeline

1 May 2026

Primary endpoint
30 April 2028

30 April 2029

Quick facts

Lead sponsor	Sheba Medical Center
Phase	Phase 1, PHASE2
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	quadruple
Primary purpose	treatment
Enrollment	41
Start date	1 May 2026
Primary completion	30 April 2028
Estimated completion	30 April 2029
Sites	1 location across Israel

Drugs / interventions tested

• 9-cis beta-Carotene-rich extract of Dunaliella alga
• Placebo Corn Oil

Conditions studied

• Retinitis Pigmentosa — all drugs for Retinitis Pigmentosa →

Sponsor

Sheba Medical Center

Who can join

18 and older, any sex, with Retinitis Pigmentosa. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.