The Effect of Oral Administration of 9-cis Rich Powder of the Alga Dunaliella Bardawil on Visual Functions in Adolescent Patients With Retinitis Pigmentosa

Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age12-18
SponsorSheba Medical Center

About this trial

The aim of this study is to determine whether 9-cis-beta Caroten rich D. Brdawiil extract is effective in the treatment of retinitis pigmentosa in adolescent patients.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Written informed consent to participate in the study.

Adolescent 12-18 years old.

Electroretinogram (ERG) responses compatible with the diagnosis of Retinitis Pigmentosa

Disqualifiers

Currently a smoker

Current use of vitamin A/ β-carotene supplements

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

History of malignancy, excepting basal or squamous cell skin carcinoma

Trial design

Design model

Crossover

Treatments tested in this trial

  • Alga Dunaliella Bardawil powder

    Dietary supplement

    9 cis beta carotene rich Alga Dunaliella Bardawil powder

  • Placebo:Starch

    Dietary supplement

    Starch powder

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Alga Dunaliella Bardawil 9-cis beta Carotene Rich PowderExperimental treatment 2 interventions
Group B: Placebo (Starch)Placebo comparator 2 interventions

Trial outcomes

Primary outcomes

1

Mean binocular maximal scotopic electroretinogram b-wave response

Using the protocol of the International Society for Clinical Electrophysiology of Vision and the "UTAS 3000" system (LKC Technologies, Gaithersburg, MD), full-field electroretinographic responses will be recorded from both eyes of each patient. For scotopic conditions, maximal ERG b-wave responses will be recorded following 30 minutes of dark adaptation.

Time frame
up to weeks 72

Secondary outcomes

1

The area within the Dark adapted chromatic Goldamann Visual field in isopters in cm2

Kinetic visual field for chromatic stimuli will be recorded in both eyes after 30 minutes of dark adaptation. Area of vision within the isopter will be measured by software in cm2.

Time frame
On weeks 0, 24, 48, 72
2

The area within Goldamann Visual field in isopters in cm2

Kinetic visual field will be recorded in both eyes. Area of vision within the isopter will be measured by software in cm2.

Time frame
On weeks 0, 24, 48, 72
3

Mean binocular maximal photopic electroretinogram b-wave response

Using the protocol of the International Society for Clinical Electrophysiology of Vision and the UTAS 3000 system (LKC Technologies, Gaithersburg, MD), full-field photopic electroretinographic responses will be recorded from both eyes of each patient.

Time frame
On weeks 0, 24, 48, 72
4

Best-corrected visual acuity (EDTRS)

Time frame
On weeks 0, 24, 48, 72

Other outcomes

Sponsors and contacts

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