NCT07509229

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

Treatment With 9-cis Beta-Carotene-Rich Extract of Dunaliella Alga in Retinitis Pigmentosa Patients - a Randomized Crossover Double Masked Study

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 41 (estimated)
• Sponsor: Sheba Medical Center · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This study is a randomized, double-masked, crossover, placebo-controlled clinical trial designed to evaluate the efficacy of a 9-cis beta-carotene-rich alga (Dunaliella) supplement in patients with Retinitis Pigmentosa (RP). The study specifically targets individuals with mutations in genes related to the retinoid cycle, a critical process for maintaining vision. Previous research has shown that prolonged treatment (at least 3 months) with 9-cis beta-carotene can lead to significant improvements in retinal function and substential visual field cahnges in a subset of RP patients. Because beta-carotene persists in the body, this study utilizes an extended 6-month washout period between treatment arms to ensure plasma levels return to baseline, allowing for a clear comparison between the active supplement and the placebo. Participants will be randomized into three blocks based on their baseline electroretinogram (ERG) b-wave responses (low, medium, or high) to ensure balanced groups. As a crossover study, every participant will complete two 3-month treatment periods: one with the active Dunaliella soft-gels and one with a corn oil placebo. The total study duration is 12 months, divided into the following phases: Initial Treatment (Months 0-3): Participants take 2 capsules twice daily of either Dunaliella oil (containing 20 mg of beta-carotene) or a placebo. Washout Period (Months 3-9): A 6-month period with no study medication to allow the supplement to clear from the system. Crossed Treatment (Months 9-12): Participants switch to the opposite treatment for a final 3 months. Participants will visit the clinic at the beginning and end of each treatment phase (Months 0, 3, 9, and 12). At these visits, the following assessments will be performed: Primary Objective: Measuring changes in retinal sensitivity via microperimetry. Secondary Objectives: Evaluating electrical retinal activity (ERG), visual acuity (ETDRS), contrast sensitivity, and retinal structure using Optical Coherence Tomography (OCT) and fundus photography. Blood samples will be analyzed for plasma levels of beta-carotene, retinol, and Retinal Binding Protein 4 (RBP4). Participants will complete the NEI VFQ-25 life quality questionnaire to assess the functional impact of the treatment. Adherence will be monitored through capsule counts at each visit, and safety will be assessed via medical history reviews and phone calls every 6 weeks.

Conditions

• Retinitis Pigmentosa

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	9-cis beta-Carotene-rich extract of Dunaliella alga	Participants will be instructed to take two soft-gel capsules twice daily (total of 4 capsules per day) for a period of 90 days. Each soft-gel capsule contains oil extraction of the alga Dunaliella, which is rich in beta-carotene (composed of approximately 70% 9-cis and 30% all-trans isomers). The capsules are manufactured by Hetchyn Ingredients Biotechnology Co., Ltd.
OTHER	Placebo Corn Oil	Participants will be instructed to take two soft-gel capsules twice daily (total of 4 capsules per day) for a period of 90 days. The placebo capsules contain corn oil and are manufactured to be identical in appearance (size, color, and texture) to the active Dunaliella soft-gels to maintain masking.

Timeline

• Start date: 2026-05-01
• Primary completion: 2028-04-30
• Completion: 2029-04-30
• First posted: 2026-04-03
• Last updated: 2026-04-03

Locations

1 site across 1 country: Israel