Dose-escalation Study to Evaluate the Safety and Tolerability of GS030 in Subjects With Retinitis Pigmentosa
Status: | Recruiting |
---|---|
Conditions: | Ocular |
Therapuetic Areas: | Ophthalmology |
Healthy: | No |
Age Range: | 18 - 75 |
Updated: | 4/6/2019 |
Start Date: | September 26, 2018 |
End Date: | January 2025 |
Contact: | Barrett Katz, MD |
Email: | bkatz@GENSIGHT-BIOLOGICS.COM |
Phone: | +1 646 831 3799 |
A Phase 1/2a, Open-Label, Non-Randomized, Dose-Escalation Study to Evaluate the Safety and Tolerability of GS030 in Subjects With Retinitis Pigmentosa
The objective of this study is to evaluate the safety and tolerability of escalating doses of
a gene therapy called GS030-DP (injected study treatment) administered via a single
intravitreal injection and repeated light stimulation using a medical device called GS030-MD
(stimulating glasses) in subjects with documented diagnosis of non-syndromic Retinitis
Pigmentosa
a gene therapy called GS030-DP (injected study treatment) administered via a single
intravitreal injection and repeated light stimulation using a medical device called GS030-MD
(stimulating glasses) in subjects with documented diagnosis of non-syndromic Retinitis
Pigmentosa
Main selection criteria:
- Age ≥18 years to ≤75 years at the time of ICF signature.
- Diagnosis of non-syndromic RP defined as:
- Clinical diagnosis of non-syndromic RP based on history, mid-peripheral visual
dysfunction, and fundoscopic appearance.
- Diagnosis of non-syndromic RP is confirmed on full-field ERG
- Visual acuity:
- Visual acuity in the dose-escalation cohorts of no better LP.
- Visual acuity in the extension cohort of no better than CF pending review of
dose-escalation cohort data by the DSMB.
- Relatively preserved ganglion cell layer volume and retinal nerve fiber layer
thickness, as measured with spectral domain optical coherence tomography (SD-OCT).
- Interpupillary distance of ≥51 mm and ≤72 mm.
- Refractive error of the study eye between -6 diopters and +6 diopters.
Main non-selection criteria
- Prior receipt of any gene therapy.
- Subjects who have undergone significant ocular surgery (per investigator
determination) within 3 months prior to Visit 1.
- Presence of narrow iridocorneal angles contraindicating pupillary dilation.
- Presence of disorders of the ocular media which interfere with visual acuity and other
ocular assessments, including SD-OCT, during the study period.
- Presence of any systemic or ocular diseases, or pathologies, other than non-syndromic
RP, or their associated therapies, that can cause or have the potential to cause
vision loss.
- Prior vitrectomy or vitreomacular surgery.
- Presence of vitreo-macular adhesion or traction, epiretinal membrane, macular pucker
and macular hole, evident by ophthalmoscopy and/or by SD-OCT examinations and assessed
by the investigator to significantly affect central vision.
- Current evidence of retinal detachment assessed by the investigator to significantly
affect central vision.
- Active ocular inflammation or recurrent history of idiopathic or autoimmune associated
uveitis.
- Presence of an Active Implantable Medical Device.
- Subjects who have undergone thermal laser procedure to the retina within 3 months of
trial entry, or any prior thermal laser procedure to the macular region.
We found this trial at
2
sites
Pittsburgh, Pennsylvania 15213
Principal Investigator: Joseph Martel, MD
Phone: 412-647-8199
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Paris, 75012
Principal Investigator: Elise BOULANGER-SCEMAMA, MD
Phone: +33 665895460
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