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Tests treatment safety and results for Leber Hereditary Optic Disease
Official title Efficacy and Safety Study of Bilateral IVT Injection of GS010 at Two Dose Levels in LHON Patients
ClinicalTrials.gov ID: NCT07303296
What this study is testing
What is GS010 High dose?
GS010 High dose is an investigational medicine, being studied as a potential treatment for leber hereditary optic disease.
Also referred to as Lumevoq, GS010.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this Clinical trial is to assess the safety and efficacy of GS010 at two dose levels on visual acuity and retinal mitochondrial activity in patients affected with ND4 Leber Hereditary Optic Neuropathy (LHON)
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 15 and older
You may be able to join if
- Aged 15 years or older at the time of vision loss onset
- Clinically manifested vision loss due to ND4 LHON in both eyes
- BCVA of at least LogMAR +2.39, measured at the FrACT scale, in both eyes
- Documented results of genotyping showing the presence of pathogenic LHON-associated mutation(s) in the ND4 mitochondrial gene and the absence of...
- Vision loss duration from 6 months to 1.5 years in the first affected eye at the Inclusion visit (Day 1)
You likely can't join if
- 1\. Any known allergy or hypersensitivity to GS010 or any of its constituents 2. Contraindication to IVT in any eye according to the Investigator's...
- Unilateral or asymmetric ND4 LHON disease: only one eye affected with a vision loss due to ND4 LHON, and the fellow eye with preserved BCVA (LogMAR 0...
- Amblyopia: unilateral treatment of the functional eye with a vision loss due to ND4 LHON;
- Patient's desire for unilateral treatment 7. Ingestion of idebenone less than 7 days prior to the Inclusion visit (Day -1) 8. Inability to tolerate...
See the full eligibility criteria
- Aged 15 years or older at the time of vision loss onset
- Clinically manifested vision loss due to ND4 LHON in both eyes
- BCVA of at least LogMAR +2.39, measured at the FrACT scale, in both eyes
- Documented results of genotyping showing the presence of pathogenic LHON-associated mutation(s) in the ND4 mitochondrial gene and the absence of other pathogenic LHON-associated mutations in the patient's mitochondrial...
- Vision loss duration from 6 months to 1.5 years in the first affected eye at the Inclusion visit (Day 1)
- No limitations to OCT image collection that would prevent high quality, reliable images from being obtained in both eyes, as determined by the reading center
- Clear ocular media and adequate pupillary dilation to permit thorough ocular examination, as assessed by the Investigator
- Human immunodeficiency virus (HIV) negative serology
- Female patients of childbearing potential must agree to use effective methods of birth control for up to 6 months after Treatment visit (Day 0). Male patients must agree to use condoms with their female partners for up...
- Willing and able to comply with the protocol, follow study instructions, attend study visits as required and complete all study assessments
- Patient - and parent/legal guardian if the patient is under 18 years of age - has provided signed, written informed consent
- 1\. Any known allergy or hypersensitivity to GS010 or any of its constituents 2. Contraindication to IVT in any eye according to the Investigator's clinical judgment and international guidelines (Avery, 2014) 3. Prior...
- Unilateral or asymmetric ND4 LHON disease: only one eye affected with a vision loss due to ND4 LHON, and the fellow eye with preserved BCVA (LogMAR 0 or close to 0);
- Amblyopia: unilateral treatment of the functional eye with a vision loss due to ND4 LHON;
- Patient's desire for unilateral treatment 7. Ingestion of idebenone less than 7 days prior to the Inclusion visit (Day -1) 8. Inability to tolerate the anti-inflammatory regimen 9. Presence of ocular disease (excluding...
The study team makes the final eligibility decision.
Where it's taking place
- Paris, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 15 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Paris, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.