A Phase 3 interventional study of GS010 and Sham Intravitreal Injection in Optic, Atrophy, Hereditary, Leber, sponsored by GenSight Biologics. Completed at 7 sites in 5 countries. Open to participants aged 15 Years and older. Per ClinicalTrials.gov, last updated 2026-03-02.
Sponsored by GenSight Biologics · Phase 3, Interventional, and Treatment
The goal of this clinical trial is to assess the effectiveness of GS010, a gene therapy, in improving the visual outcome in participants with Leber Hereditary Optic Neuropathy (LHON) due to the G11778A ND4 mitochondrial mutation when vision loss is present for more than six months and up to one year.
44 studies on the registry are indexed under Optic Atrophy, Hereditary, Leber; 9 are open to participants now.
This study's enrollment of 37 is close to the median of 36 across 31 interventional studies indexed under Optic Atrophy, Hereditary, Leber.
Browse Optic Atrophy, Hereditary, Leber studies →GenSight Biologics is the lead sponsor of 9 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Selection Criteria:
Participants must meet all the following criteria at the Screening Visit (Visit 1) in order to be included into the study.
Inclusion Criteria:
Participants included in the study must satisfy all the following criteria at the Inclusion Visit (Visit 2).
Exclusion Criteria:
Non-Selection Criteria:
Participants who meet at least one of the following criteria at the Screening Visit (Visit 1) will not be included into the study.
Exclusion Criteria:
Participants who meet at least one of the following criteria at the Inclusion Visit (Visit 2) will not be included in the study.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Each participant will have one eye randomly selected to receive a single injection of GS010 and the other eye will receive a sham injection. GS010-treated Eyes: GS010 is a recombinant adeno-associated viral vector serotype 2 (rAAV2/2) containing the wild-type ND4 gene (rAAV2/2-ND4). Participants will receive a single dose of GS010 in one of their randomly selected eyes, via intravitreal injection containing 9E10 viral genomes in 90μL balanced salt solution (BSS) plus 0.001% Pluronic F68®.
Biological: GS010
Each participant will have one eye randomly selected to receive GS010 and the other eye will receive a sham injection. Eyes receiving sham injection will undergo the same preparatory procedures as eyes receiving GS010 injection, including pupillary dilation, topical anti-infection and topical anesthetic procedures. Sham Intravitreal injection will be performed by applying pressure to the eye at the location of a typical intravitreal injection procedure using the blunt end of a syringe without a needle.
Device: Sham Intravitreal Injection
Both eyes of each participant will receive standard antiseptic preparation, administration of topical local ocular anesthetic agents and will undergo pupillary dilation. Administration of an intra-ocular pressure lowering agent will precede treatment for every participant. GS010-treated Eyes: GS010 is a recombinant adeno-associated viral vector serotype 2 (rAAV2/2) containing the wild-type ND4 gene (rAAV2/2-ND4). Participants will receive a single dose of GS010 in one of their randomly selected eyes, via intravitreal injection containing 9E10 viral genomes in 90μL balanced salt solution (BSS) plus 0.001% Pluronic F68®.
Also known as: Lenadogene Nolparvovec, rAAV2/2-ND4
Both eyes of each participant will receive standard antiseptic preparation, administration of topical local ocular anesthetic agents and will undergo pupillary dilation. Administration of an intra-ocular pressure lowering agent will precede treatment for every participant. Sham-treated Eyes: One eye of each participant will undergo sham injection. Sham Intravitreal injection will be performed by applying pressure to the eye at the location of a typical intravitreal injection procedure using the blunt end of a syringe without a needle.
Change From Baseline in ETDRS Visual Acuity (Quantitative Score) at Week 48
Visual acuity was derived from the Early Treatment Diabetic Retinopathy Study (ETDRS) chart. The visual acuity logarithm of the minimal angle of resolution (LogMAR) score was derived from the number of letters participants could read on the ETDRS chart. 1 ETDRS line = 5 letters 1 ETDRS line = 0.1 LogMAR A lower LogMAR score denotes better visual acuity and a negative change from baseline indicates an improvement in visual acuity. Change = (Week 48 score - Baseline score).
Time frame: Baseline and Week 48
Change From Baseline in ETDRS Visual Acuity (Quantitative Score) at Week 96
Visual acuity was derived from the Early Treatment Diabetic Retinopathy Study (ETDRS) chart. The visual acuity logarithm of the minimal angle of resolution (LogMAR) score was derived from the number of letters participants could read on the ETDRS chart. 1 ETDRS line = 5 letters 1 ETDRS line = 0.1 LogMAR A lower LogMAR score denotes better visual acuity and a negative change from baseline indicates an improvement in visual acuity. Change = (Week 96 score - Baseline score).
Time frame: Baseline and Week 96
Number of Eye Responders to Treatment at Week 48 and Week 96
An eye was determined as a responder to treatment based on 2 different definitions. Definition 1: An eye responder was defined by an improvement of the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity score of at least 15 letters compared to Baseline, or a final visual acuity greater than a Snellen acuity equivalent of 20/200 (a score of at least 1 letter). Definition 2: An eye responder was defined by an improvement of the ETDRS score of at least 20 letters compared to Baseline.
Time frame: Baseline; Week 48 and Week 96
Number of Subject Responders to Treatment at Week 48 and Week 96
A subject responder was defined as a participant whose Early Treatment Diabetic Retinopathy Study (ETDRS) score of the treated eye (that received GS010), was at least 15 letters better than the sham eye, or whose treated eye had a logarithm of the minimal angle of resolution (logMAR) acuity score of at least 0.3 logMAR better than the sham eye.
Time frame: Week 48 and Week 96
Change From Baseline in GCL Macular Volume at Week 48 and Week 96
Ganglion cell layer (GCL) macular volume was measured as a parameter of spectral domain-optical coherence tomography (SD-OCT). SD-OCT was obtained with the Spectralis® OCT (Heidelberg Engineering).
Time frame: Baseline and Week 48; Baseline and Week 96
Change From Baseline in RNFL Temporal Quadrant Thickness at Week 48 and Week 96
Retinal nerve fiber layer (RNFL) temporal quadrant thickness was measured as a parameter of spectral domain-optical coherence tomography (SD-OCT). SD-OCT was obtained with the Spectralis® OCT (Heidelberg Engineering).
Time frame: Baseline and Week 48; Baseline and Week 96
Change From Baseline in Papillomacular Bundle Thickness at Week 48 and Week 96
Papillomacular bundle thickness was measured as a parameter of spectral domain-optical coherence tomography (SD-OCT). SD-OCT was obtained with the Spectralis® OCT (Heidelberg Engineering).
Time frame: Baseline and Week 48; Baseline and Week 96
Change From Baseline in ETDRS Total Macular Volume at Week 48 and Week 96
Early Treatment Diabetic Retinopathy Study (ETDRS) total macular volume was measured as a parameter of spectral domain-optical coherence tomography (SD-OCT). SD-OCT was obtained with the Spectralis® OCT (Heidelberg Engineering).
Time frame: Baseline and Week 48; Baseline and Week 96
Change From Baseline in the Foveal Threshold Sensitivities Obtained With HVF Analyzer II at Week 48 and Week 96
The assessment of standardized automated visual fields was measured using the Humphrey Visual Field (HVF) Analyzer II. Automated visual fields included the assessment of foveal threshold sensitivities. Foveal threshold sensitivity is measured in decibels (dB), which ranges from 0 dB to 50 dB. A sensitivity threshold of 0 dB indicates not being able to see the most intense perimetric stimulus, while higher dB indicates better/normal foveal vision. A positive change from baseline indicates an improvement of symptoms.
Time frame: Baseline and Week 48; Baseline and Week 96
Visual Field Mean Deviation in Decibels of Sensitivity Obtained With HVF Analyzer II at Week 48 and Week 96
The assessment of standardized automated visual fields was measured using the Humphrey Visual Field (HVF) Analyzer II. Automated visual fields included the assessment of the mean deviation (MD) in decibels (dB) of sensitivity.
Time frame: Baseline, Week 48 and Week 96
Change From Baseline in Contrast Sensitivity at Week 48 and Week 96
The assessment of contrast sensitivity was measured using the Pelli-Robson chart. The chart uses letters arranged in groups whose contrast varies from high to low. Participants read the letters, starting with the highest contrast, until they are unable to read 2 or 3 letters in a single group. Each eye is assigned a score based on the contrast of the last group in which 2 or 3 letters were correctly read, ranging from 0 to 2.2 "log of contrast sensitivity" (LogCS) units. A score of 2.0 LogCS, represents a normal sensitivity contrast, and indicates the eye was able to detect 2 of the 3 letters with a contrast of 1 percent (contrast sensitivity = 100 percent or log 2). Scores less than 2.0 signify poorer contrast sensitivity. Pelli-Robson contrast sensitivity score of less than 1.5 is consistent with visual impairment and a score of less than 1.0 represents in visual disability. A positive change from baseline indicates improvement in symptoms.
Time frame: Baseline and Week 48; Baseline and Week 96
Change From Baseline in Color Vision
The assessment of color vision was measured using the Farnsworth-Munsell 100-Hue Color Test. Each of the 4 trays consisted of 21 caps. Participants were asked to sort the randomly arranged caps following the hue order from the first to the last fixed caps. The total error score (TES) was derived by the frequency the caps were misplaced and the severity, or distance of the misplacement. Errors were made whenever caps were misplaced from the correct order. Error scores were calculated according to the distance between any two caps. The error score for each individual cap was the sum of the difference between the number of that cap and the numbers of the cap adjacent to it, minus 2. TES was the total sum of the error scores of the entire set of caps. The best possible score was 0 and there is no defined upper limit to the total error score range. A lower score indicates improved color discrimination ability. A negative change from baseline indicates an improvement in symptoms.
Time frame: Baseline and Week 48; Baseline and Week 96
| Milestone | All Participants |
|---|---|
| Started | 37 |
| Completed | 37 |
| Not completed | 0 |
Visual acuity was derived from the Early Treatment Diabetic Retinopathy Study (ETDRS) chart. The visual acuity logarithm of the minimal angle of resolution (LogMAR) score was derived from the number of letters participants could read on the ETDRS chart. 1 ETDRS line = 5 letters 1 ETDRS line = 0.1 LogMAR A lower LogMAR score denotes better visual acuity and a negative change from baseline indicates an improvement in visual acuity. Change = (Week 48 score - Baseline score).
| LogMAR | GS010-treated Eyes | Sham-treated Eyes |
|---|---|---|
| Change From Baseline in ETDRS Visual Acuity (Quantitative Score) at Week 48 | -0.219 ± 0.055 | -0.211 ± 0.055 |
Visual acuity was derived from the Early Treatment Diabetic Retinopathy Study (ETDRS) chart. The visual acuity logarithm of the minimal angle of resolution (LogMAR) score was derived from the number of letters participants could read on the ETDRS chart. 1 ETDRS line = 5 letters 1 ETDRS line = 0.1 LogMAR A lower LogMAR score denotes better visual acuity and a negative change from baseline indicates an improvement in visual acuity. Change = (Week 96 score - Baseline score).
| LogMAR | GS010-treated Eyes | Sham-treated Eyes |
|---|---|---|
| Change From Baseline in ETDRS Visual Acuity (Quantitative Score) at Week 96 | -0.308 ± 0.068 | -0.259 ± 0.068 |
An eye was determined as a responder to treatment based on 2 different definitions. Definition 1: An eye responder was defined by an improvement of the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity score of at least 15 letters compared to Baseline, or a final visual acuity greater than a Snellen acuity equivalent of 20/200 (a score of at least 1 letter). Definition 2: An eye responder was defined by an improvement of the ETDRS score of at least 20 letters compared to Baseline.
| Eyes | GS010-treated Eyes | Sham-treated Eyes |
|---|---|---|
| Definition 1: Week 48 | 7 | 5 |
| Definition 1: Week 96 | 12 | 6 |
| Definition 2: Week 48 | 10 | 13 |
| Definition 2: Week 96 | 17 | 19 |
A subject responder was defined as a participant whose Early Treatment Diabetic Retinopathy Study (ETDRS) score of the treated eye (that received GS010), was at least 15 letters better than the sham eye, or whose treated eye had a logarithm of the minimal angle of resolution (logMAR) acuity score of at least 0.3 logMAR better than the sham eye.
| Participants | All Participants |
|---|---|
| Week 48 | 37 |
| Week 96 | 37 |
Ganglion cell layer (GCL) macular volume was measured as a parameter of spectral domain-optical coherence tomography (SD-OCT). SD-OCT was obtained with the Spectralis® OCT (Heidelberg Engineering).
| mm^3 | GS010-treated Eyes | Sham-treated Eyes |
|---|---|---|
| Week 48 | -0.003 ± 0.012 | -0.038 ± 0.012 |
| Week 96 | -0.018 ± 0.012 | -0.031 ± 0.012 |
Retinal nerve fiber layer (RNFL) temporal quadrant thickness was measured as a parameter of spectral domain-optical coherence tomography (SD-OCT). SD-OCT was obtained with the Spectralis® OCT (Heidelberg Engineering).
| µm | GS010-treated Eyes | Sham-treated Eyes |
|---|---|---|
| Week 48 | -0.562 ± 0.988 | -3.354 ± 1.017 |
| Week 96 | -1.791 ± 0.974 | -2.042 ± 0.951 |
Papillomacular bundle thickness was measured as a parameter of spectral domain-optical coherence tomography (SD-OCT). SD-OCT was obtained with the Spectralis® OCT (Heidelberg Engineering).
| µm | GS010-treated Eyes | Sham-treated Eyes |
|---|---|---|
| Week 48 | 1.6 ± 1.3 | -1.0 ± 1.4 |
| Week 96 | 1.2 ± 1.3 | 0.7 ± 1.3 |
Early Treatment Diabetic Retinopathy Study (ETDRS) total macular volume was measured as a parameter of spectral domain-optical coherence tomography (SD-OCT). SD-OCT was obtained with the Spectralis® OCT (Heidelberg Engineering).
| mm^3 | GS010-treated Eyes | Sham-treated Eyes |
|---|---|---|
| Week 48 | -0.104 ± 0.046 | -0.224 ± 0.046 |
| Week 96 | -0.200 ± 0.037 | -0.265 ± 0.037 |
The assessment of standardized automated visual fields was measured using the Humphrey Visual Field (HVF) Analyzer II. Automated visual fields included the assessment of foveal threshold sensitivities. Foveal threshold sensitivity is measured in decibels (dB), which ranges from 0 dB to 50 dB. A sensitivity threshold of 0 dB indicates not being able to see the most intense perimetric stimulus, while higher dB indicates better/normal foveal vision. A positive change from baseline indicates an improvement of symptoms.
| decibels (dB) | GS010-treated Eyes | Sham-treated Eyes |
|---|---|---|
| Week 48 | 0.7 ± 8.9 | -0.5 ± 11.9 |
| Week 96 | 1.3 ± 8.0 | 2.4 ± 10.8 |
The assessment of standardized automated visual fields was measured using the Humphrey Visual Field (HVF) Analyzer II. Automated visual fields included the assessment of the mean deviation (MD) in decibels (dB) of sensitivity.
| decibels (dB) | GS010-treated Eyes | Sham-treated Eyes |
|---|---|---|
| Baseline MD | -25.99 ± 8.37 | -24.94 ± 9.70 |
| Week 48 MD | -22.83 ± 9.43 | -22.94 ± 9.80 |
| Week 96 MD | -23.22 ± 8.98 | -22.43 ± 9.39 |
The assessment of contrast sensitivity was measured using the Pelli-Robson chart. The chart uses letters arranged in groups whose contrast varies from high to low. Participants read the letters, starting with the highest contrast, until they are unable to read 2 or 3 letters in a single group. Each eye is assigned a score based on the contrast of the last group in which 2 or 3 letters were correctly read, ranging from 0 to 2.2 "log of contrast sensitivity" (LogCS) units. A score of 2.0 LogCS, represents a normal sensitivity contrast, and indicates the eye was able to detect 2 of the 3 letters with a contrast of 1 percent (contrast sensitivity = 100 percent or log 2). Scores less than 2.0 signify poorer contrast sensitivity. Pelli-Robson contrast sensitivity score of less than 1.5 is consistent with visual impairment and a score of less than 1.0 represents in visual disability. A positive change from baseline indicates improvement in symptoms.
| LogCS | GS010-treated Eyes | Sham-treated Eyes |
|---|---|---|
| Week 48 | 0.19 ± 0.05 | 0.09 ± 0.05 |
| Week 96 | 0.22 ± 0.06 | 0.12 ± 0.06 |
The assessment of color vision was measured using the Farnsworth-Munsell 100-Hue Color Test. Each of the 4 trays consisted of 21 caps. Participants were asked to sort the randomly arranged caps following the hue order from the first to the last fixed caps. The total error score (TES) was derived by the frequency the caps were misplaced and the severity, or distance of the misplacement. Errors were made whenever caps were misplaced from the correct order. Error scores were calculated according to the distance between any two caps. The error score for each individual cap was the sum of the difference between the number of that cap and the numbers of the cap adjacent to it, minus 2. TES was the total sum of the error scores of the entire set of caps. The best possible score was 0 and there is no defined upper limit to the total error score range. A lower score indicates improved color discrimination ability. A negative change from baseline indicates an improvement in symptoms.
| score on a scale | GS010-treated Eyes | Sham-treated Eyes |
|---|---|---|
| Week 48 | -30.0 ± 255.0 | -44.3 ± 182.2 |
| Week 96 | -10.3 ± 247.3 | -61.0 ± 188.9 |
Collected over From first dose to end of study (a maximum of 96 weeks). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| All Participants | 0/37 (0%) | 3/37 (8.1%) | 37/37 (100%) |
| Event | All Participants |
|---|---|
| Acute myocardial infarctionCardiac disorders | 1/37 |
| Retinal tearEye disorders | 1/37 |
| Intestinal perforationGastrointestinal disorders | 1/37 |
| DiverticulitisInfections and infestations | 1/37 |
| Event | All Participants |
|---|---|
| IridocyclitisEye disorders | 15/37 |
| Punctate keratitisEye disorders | 15/37 |
| Autoimmune uveitisEye disorders | 14/37 |
| Keratic precipitatesEye disorders | 13/37 |
| Intraocular pressure increasedEye disorders | 11/37 |
| Anterior chamber cellEye disorders | 9/37 |
| Gamma-glutamyl transferase increasedInvestigations | 8/37 |
| Vitreal cellsEye disorders | 7/37 |
| Conjunctival haemorrhageEye disorders | 6/37 |
| Conjunctival hyperaemiaEye disorders | 6/37 |
| Age, Categorical(Participants) | All Participants |
|---|---|
| <=18 years | 4 |
| Between 18 and 65 years | 32 |
| >=65 years | 1 |
| Age, Continuous(years) | All Participants |
|---|---|
| Mean | 34.2 ± 15.2 |
| Sex: Female, Male(Participants) | All Participants |
|---|---|
| Female | 8 |
| Male | 29 |
| Race and Ethnicity Not Collected(Participants) | All Participants |
|---|
| Region of Enrollment(Participants) | All Participants |
|---|---|
| United States | 20 |
| United Kingdom | 2 |
| France | 5 |
| Germany | 6 |
| Italy | 4 |
| Weight(kilograms) | All Participants |
|---|---|
| Mean | 80.1 ± 21.0 |
| Height(centimetres) | All Participants |
|---|---|
| Mean | 174.4 ± 7.8 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Jan 2016 to primary completion in Jan 2018, 24 months.
Results were first posted in Jan 2020, 2 years after primary completion.
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