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Gene Therapy
Gene Therapy for Retinitis Pigmentosa (RESTORE Trial)
Phase 2
Waitlist Available
Research Sponsored by Nanoscope Therapeutics Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age ≥ 18 years
Confirmed diagnosis of Advanced Retinitis Pigmentosa (RP) based on clinical examination, dilated fundus examination, and genetic testing.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weeks 16,24,32,52,76,100
Awards & highlights
RESTORE Trial Summary
This trial will test if a single injection of vMCO-010 is safe and effective in treating a certain eye condition.
Who is the study for?
Adults over 18 with advanced Retinitis Pigmentosa (RP) and very poor vision can join this trial. They must have a confirmed diagnosis of RP, some remaining retinal layers visible on OCT scans, and understand the study to give consent. Excluded are those with other eye diseases like glaucoma, recent eye surgery, or infections like HIV; those who've had gene therapy before; or cannot perform mobility tests.Check my eligibility
What is being tested?
The trial is testing MCO-010 optogenetic therapy involving one injection into the eye compared to a sham procedure. It aims to see if this gene therapy product can safely improve vision in people with severe visual impairment due to RP.See study design
What are the potential side effects?
Potential side effects may include typical risks associated with intravitreal injections such as eye inflammation, increased intraocular pressure, cataracts formation, retinal detachment or bleeding inside the eye.
RESTORE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I have been diagnosed with advanced Retinitis Pigmentosa.
RESTORE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ weeks 16,24,32,52,76,100
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 16,24,32,52,76,100
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Efficacy of a single intravitreal injection of Multi-Characteristic Opsin (MCO-010) as assessed by best corrected visual acuity.
Secondary outcome measures
Efficacy of MCO-010 as assessed by best corrected visual acuity.
Efficacy of MCO-010 as assessed by mobility testing.
Efficacy of MCO-010 as assessed by static shape recognition assay.
+1 moreOther outcome measures
Efficacy of MCO-010 as assessed by a composite of functional assessments.
Safety of MCO-010.
RESTORE Trial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: MCO-010- Low DoseExperimental Treatment1 Intervention
Participants receive 0.9E11gc/eye of MCO-010
Group II: MCO-010- High DoseExperimental Treatment1 Intervention
Participants receive 1.2E11gc/eye of MCO-010
Group III: Sham InjectionPlacebo Group1 Intervention
Participants receive sham injection
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gene Therapy Product-MCO-010
2021
Completed Phase 2
~30
Find a Location
Who is running the clinical trial?
Nanoscope Therapeutics Inc.Lead Sponsor
6 Previous Clinical Trials
87 Total Patients Enrolled
4 Trials studying Retinitis Pigmentosa
75 Patients Enrolled for Retinitis Pigmentosa
Aaron Osborne, MDStudy ChairNanoscope Therapeutics Inc.
1 Previous Clinical Trials
6 Total Patients Enrolled
Mohamed Genead, MDStudy DirectorNanoscope Therapeutics Inc.
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had eye surgery in the study eye within the last 3 months.My study eye does not have glaucoma, significant vision loss, active inflammation, or cloudiness.I don't have eye conditions that could affect vision tests.I have ongoing eye inflammation or a history of eye inflammation without a known cause.I understand the study details and agree to participate.My eye condition prevents pupil dilation.I have received a retinal prosthesis or gene/stem cell therapy.You have a medical device implanted in your body that is currently functioning.My central vision is significantly affected due to retinal detachment in one eye.I am 18 years old or older.My eye has a condition affecting my central vision, confirmed by eye exams.I have been diagnosed with advanced Retinitis Pigmentosa.I am not taking hydroxychloroquine, chloroquine, or similar drugs.I do not have any other serious illnesses that could affect my brain function.I have advanced retinitis pigmentosa.
Research Study Groups:
This trial has the following groups:- Group 1: MCO-010- Low Dose
- Group 2: MCO-010- High Dose
- Group 3: Sham Injection
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Retinitis Pigmentosa Patient Testimony for trial: Trial Name: NCT04945772 — Phase 2
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To what degree is Gene Therapy Product-vMCO-010 hazardous to users?
"Our team at Power believes that Gene Therapy Product-vMCO-010 is a safe option, awarding it the score of 2. This assessment was based off the Phase 2 trial data which showed promising safety results but lacked evidence for efficacy."
Answered by AI
How many medical institutions have implemented this research endeavor in the city?
"This experiment is being conducted in 6 distinct locations, with Beverly Hills, McAllen and Fargo included. To reduce the strain of transportation should you decide to take part, it's best to pick a site close by."
Answered by AI
What primary goals is this research attempting to accomplish?
"This medical trial has a primary outcome of assessing the efficacy of intravitreal injection of virally-carried Multi-Characteristic Opsin (vMCO-010) as evaluated by Y Mobility Test over 100 weeks. Secondary outcomes include changes to light sensitivity, visual field and functional vision determined by Full Field Stimulus Threshold (FST), perimetry, National Eye Institute Visual Function Questionnaire 25 with responses range from 0 to 5, 0 to 6 or 0 to 10 in percentages."
Answered by AI
Are there still opportunities for volunteers to join this clinical examination?
"According to clinicaltrials.gov, this particular medical study is no longer seeking patients. The trial was first published on July 13th 2021 and last updated the same day in 2022. Although participants are not accepted at present, there are 273 other trials open for enrollment presently."
Answered by AI
Who else is applying?
What state do they live in?
California
Florida
Other
Texas
How old are they?
65+
18 - 65
What site did they apply to?
Other
Nanoscope Clinical Site
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
Because I suffer from this. trying to maintain sight I have. I hope to improve eyesight for myself or others.
PatientReceived 2+ prior treatments
I am suffering from retina disorder over 40 years. I want to recover My vision with mco-010 trial injection.
PatientReceived 1 prior treatment
What questions have other patients asked about this trial?
How long is the trail ? Is there a clinical trial that I could apply for now or in the near future?
PatientReceived 1 prior treatment
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