Expanded Access Use for a single patient of Bilateral Intravitreal Injection of GS010 in a Single Subject Affected with G11778A ND4 Leber Hereditary Optic Neuropathy
Who can participate
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
The EAP applies to patients not eligible to ongoing GS010 clinical trials.
Inclusion Criteria:
* Presence of documented G11778A ND4 LHON-causing mutation
* Signature of informed consent and assent from the parent/guardian and the patient.
Exclusion Criteria:
Contraindications to GS010 product or IVT procedures are to be checked prior to consent signature and treatment injection:
* Any known allergy or hypersensitivity to GS010 or its constituents.
* Contraindication to intravitreal injection in any eye.
* Intravitreal drug delivery to any eye within 30 days prior to the injection
* Previous vitrectomy in either eye.
* Narrow angle in any eye contra-indicating pupillary dilation.
* Presence of disorders or diseases of the eye or adnexa, excluding LHON, which may interfere with visual or ocular assessments, including SD-OCT, during the study period.
* Presence of known/documented mutations, other than the G11778A ND4 LHON-causing mutation, which are known to cause pathology of the optic nerve, retina or afferent visual system.
* Presence of systemic or ocular/vision diseases, disorders or pathologies, other than LHON, known to cause or be associated with vision loss, or whose associated treatment(s) or therapy(ies) is/are known to cause or be associated with vision loss.
* Presence of optic neuropathy from any cause except LHON.
* Presence of illness or disease that, in the opinion of the Investigator, include symptoms and/or the associated treatments that can alter visual…