Dose-Escalation Study to Evaluate the Safety and Tolerability of Intravitreal vMCO-I in Patients … (NCT04919473) | Clinical Trial Compass
CompletedPhase 1/2
Dose-Escalation Study to Evaluate the Safety and Tolerability of Intravitreal vMCO-I in Patients With Advanced Retinitis Pigmentosa
India11 participantsStarted 2019-10-23
Plain-language summary
The purpose of the study is to evaluate the safety and tolerability of a single intravitreal injection of virally-carried Multi-Characteristic Opsin I (vMCO-I)
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Age \> 18 years
✓. Diagnosis of advanced RP using Fundus Photographs
✓. Clinical diagnosis of advanced retinal dystrophy
✓. Snellen's visual acuity equivalent LP/NLP in worse (study) eye
✓. Visual acuity in the non-study eye of no-better-than finger counting
✓. Presence of retinal bipolar cells and retinal nerve fiber layer on OCT testing
Exclusion criteria
✕. Prior participation in a clinical study (ocular or non-ocular) with an investigational drug, agent or therapy or any gene or stem cell therapy in the past six months.
✕. Concurrent participation in another interventional clinical ocular study.
✕. Pre-existing eye conditions such as glaucoma, diseases affecting the optic nerve causing significant visual field loss, active uveitis, corneal or lenticular opacities).
✕. Presence of any complicating systemic diseases such as malignancies whose treatment could affect central nervous system function.
✕. Subjects who are positive for hepatitis B, C, and HIV will be excluded.
What they're measuring
1
The safety and tolerability of escalating doses of vMCO-l administered via a single IVT in subjects with advanced Retinitis Pigmentosa