Retinitis PigmentosaPhase 2NCT02837640
Studying a Potential Protective Effect of L-Dopa on Retinitis Pigmentosa
A Phase 2 study testing levodopa-carbidopa in people with Retinitis Pigmentosa, run by Beirut Eye Specialist Hospital at 1 site in Lebanon.
Trial summary
The purpose of this study is to evaluate the effect of L-Dopa on the progression of retinitis pigmentosa. Read more about this study
- Who is it for?
- Ages 10 to 65 years
- Conditions the study is for
- Retinitis Pigmentosa
- What is being tested?
- levodopa-carbidopa
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteLebanon
- Study dates
- Jun 2016to Jun 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All confirmed cases of retinitis pigmentosa
- VA of 20/400 or better
Who cannot join
- Advanced stages of retinitis pigmentosa with poor best corrected visual acuity (less than 20/400)
- co-existing eye morbidities interfering with retinitis pigmentosa (glaucoma, retinal detachment...)
- Flat electroretinogram
- Intolerance or counterindication to drug
- Unability for long-term follow-up
Trial locations and contacts
1 site in 1 country.
Lebanon1 site, 1 recruiting
- Recruiting
Beirut Eye Specialist Hospital
Beirut, 116-5311
George Cherfan, MD, Prof, +961 1 423111 ext. 160, georgecherfan@gmail.com
About this study
Official title: The Effect of L-Dopa on the Progression of Retinitis Pigmentosa
The purpose of this study is to evaluate the effect of L-Dopa on the progression of retinitis pigmentosa.
Read the detailed description
Retinitis pigmentosa is a group of progressive hereditary diseases that diffusely affects the functioning of photoreceptors and the pigment epithelium. It may be speculated that a protective effect on the pigment epithelium, as it is supposed for L-Dopa, can slow the progression of the disease or even lead to an, at least transient, improvement of visual functions. To evaluate the effect of L-Dopa on retinitis pigmentosa progression, visual acuity, electroretinogram and visual field will be preformed regularly.
- Conditions
- Retinitis Pigmentosa
- Being tested
- levodopa-carbidopa
- Keywords
- Retinitis Pigmentosa, Levodopa
- Medical subject headings
- Retinitis Pigmentosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
levodopa-carbidopaDrug
Also called Sinemet 200/50
sinemet 200/50 1/2 tablet b.i.d. for 2 days and then t.i.d for 6 months
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | This is a single armed study. All patients included will receive treatment. Control will happen with data from the same patients before they received treatment.
patients will receive sinemet 200/50 1/2 tablet (levodopa-carbidopa 100/25) b.i.d for two days and then will be increased to t.i.d. for 6 months. Receives: Drug: levodopa-carbidopa |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Electroretinogram
the electric response to light stimuli of the retina, in millivolt, will be measured. The electroretinogram shows a-waves (elicit information about the function of the photoreceptors) and b-waves (elicit information about other neurosensory structure of the retina)
Measured: Baseline, 1 year, 2 years, 5 years
Secondary outcomes (2)
Change in Visual Acuity
Visual acuity will be measured using Snellen chart
Measured: Baseline, 6 months, 1 year, 2 years, 5 years
Change in Visual Field
Using 24-2 Humphrey Visual Field Analyzer, the progress in visual field defect will be measured, comparing mean deviation (dB) and pattern standard deviation (dB)
Measured: Baseline, 1 year, 2 years, 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2016 (estimated)
- Study startJun 2016
- Primary completionJun 2017 (estimated)
- Study completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Retinitis PigmentosaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beirut Eye Specialist Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elias F. Jarade, MD, Principal investigator, Beirut Eye Specialist Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02837640
- Sponsor's protocol ID
- RP DOPA
- Status last verified
- Jul 2016
- First submitted
- 22 Jun 2016
- Last updated
- 19 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: Individual participant date will not be shared at the moment being, since it is not of value unless it is thoroughly analysed.
Publications
Brilliant MH, Vaziri K, Connor TB Jr, Schwartz SG, Carroll JJ, McCarty CA, Schrodi SJ, Hebbring SJ, Kishor KS, Flynn HW Jr, Moshfeghi AA, Moshfeghi DM, Fini ME, McKay BS. Mining Retrospective Data for Virtual Prospective Drug Repurposing: L-DOPA and Age-related Macular Degeneration. Am J Med. 2016 Mar;129(3):292-8. doi: 10.1016/j.amjmed.2015.10.015. Epub 2015 Oct 30.
PubMed 26524704
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of L-Dopa on the Progression of Retinitis Pigmentosa
- ClinicalTrials.gov ID
- NCT02837640
- Acronym / sponsor ID
- RP DOPA
- Conditions
- Retinitis Pigmentosa
- Keywords
- Retinitis Pigmentosa, Levodopa
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Beirut Eye Specialist HospitalUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 19 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the effect of L-Dopa on the progression of retinitis pigmentosa.
Detailed description
Retinitis pigmentosa is a group of progressive hereditary diseases that diffusely affects the functioning of photoreceptors and the pigment epithelium. It may be speculated that a protective effect on the pigment epithelium, as it is supposed for L-Dopa, can slow the progression of the disease or even lead to an, at least transient, improvement of visual functions. To evaluate the effect of L-Dopa on retinitis pigmentosa progression, visual acuity, electroretinogram and visual field will be preformed regularly.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: levodopa-carbidopaThis is a single armed study. All patients included will receive treatment. Control will happen with data from the same patients before they received treatment. patients will receive sinemet 200/50 1/2 tablet (levodopa-carbidopa 100/25) b.i.d for two days and then will be increased to t.i.d. for 6 months. |
Who may qualify
- Ages
- 10 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- All confirmed cases of retinitis pigmentosa
- VA of 20/400 or better
Key exclusion criteria (5 listed)
- Advanced stages of retinitis pigmentosa with poor best corrected visual acuity (less than 20/400)
- co-existing eye morbidities interfering with retinitis pigmentosa (glaucoma, retinal detachment...)
- Flat electroretinogram
- Intolerance or counterindication to drug
- Unability for long-term follow-up
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| levodopa-carbidopaAlso: Sinemet 200/50sinemet 200/50 1/2 tablet b.i.d. for 2 days and then t.i.d for 6 months | Drug | Treatment |
Primary outcome
Change in Electroretinogram
Time frame: Baseline, 1 year, 2 years, 5 years
the electric response to light stimuli of the retina, in millivolt, will be measured. The electroretinogram shows a-waves (elicit information about the function of the photoreceptors) and b-waves (elicit information about other neurosensory structure of the retina)
2 secondary outcomes
Change in Visual Acuity
Time frame: Baseline, 6 months, 1 year, 2 years, 5 years
Change in Visual Field
Time frame: Baseline, 1 year, 2 years, 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2016.
- Background: PubMed 26524704Brilliant MH, Vaziri K, Connor TB Jr, Schwartz SG, Carroll JJ, McCarty CA, Schrodi SJ, Hebbring SJ, Kishor KS, Flynn HW Jr, Moshfeghi AA, Moshfeghi DM, Fini ME, McKay BS. Mining Retrospective Data for Virtual Prospective Drug Repurposing: L-DOPA and Age-related Macular Degeneration. Am J Med. 2016 Mar;129(3):292-8. doi: 10.1016/j.amjmed.2015.10.015. Epub 2015 Oct 30.
- Individual participant dataSharing planned: No. Individual participant date will not be shared at the moment being, since it is not of value unless it is thoroughly analysed.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elias F. Jarade, MD principal investigator
Beirut Eye Specialist Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing levodopa-carbidopa in people with Retinitis Pigmentosa, run by Beirut Eye Specialist Hospital at 1 site in Lebanon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lebanon. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elias F. Jarade, MD (+9613549297, ejarade@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Electroretinogram (time frame: Baseline, 1 year, 2 years, 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02837640, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2016.