NCT07509229Enrolling by invitationPhase 1/2
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
Source: ClinicalTrials.gov · Last updated 27 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 41 (estimated)
- First submitted
- 11 Mar 2026
- Start date
- Jul 2026
- Primary completion date
- Apr 2028
- Lead sponsor
- Sheba Medical Center
- Diseases
- Retinitis pigmentosa
- NCT number
- NCT07509229
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 41
- From Jul 2026 to the primary completion date, Apr 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Active arterial disease within 3 months prior to enrolment in the study, e.g. unstable angina, myocardial infarction, transient ischemic attack, stroke, coronary artery bypass graft surgery
- Participation in another investigational drug study within 4 weeks prior to enrolment
- Initiation of hormone replacement therapy or oral contraceptive therapy within 3 months prior to enrolment
Other illness
- History of malignancy, excepting basal or squamous cell skin carcinoma
- Uncontrolled hypertension, defined either as resting diastolic blood pressure \>95 mmHg (taken from the mean of 3 readings) or as resting systolic blood pressure \>180 mmHg
- History of alcohol abuse or drug abuse or both
- Uncontrolled endocrine or metabolic disease
- Serious or unstable medical or psychological condition which, in the opinion of the PI, would compromise the subject's safety or successful participation in the study
Other
- Currently a smoker
- Current use of vitamin A/ β-carotene supplements
- Known mutations in the ABCA4 gene
- Women who are pregnant, or breast feeding, or are premenopausal but not using chemical or mechanical contraception
- Intention to engage in vigorous exercise or an aggressive diet regimen
Who the study is looking for
- Written informed consent to participate in the study
- Men or women aged 18 years or older
- Electroretinogram (ERG) responses compatible with the diagnosis of retinitis pigmentosa
- Positive for mutation(s) in retinoid cycle related genes
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Goldschleger Eye Institute, Sheba Medical Center, Coordinator of this site? Confirm its status | Tel HaShomer | Israel | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.