Status:
COMPLETED
Dose-Escalation Study to Evaluate the Safety and Tolerability of Intravitreal vMCO-I in Patients With Advanced Retinitis Pigmentosa
Lead Sponsor:
Nanoscope Therapeutics Inc.
Conditions:
Retinitis Pigmentosa
Retinal Diseases
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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)
Detailed Description
This open label dose-escalation study evaluated 2 dose levels in up to 11 subjects of retinitis pigmentosa (3 in low dose and 8 in high dose per dose) with active vMCO-010. Subjects with confirmed dia...
Eligibility Criteria
Inclusion
- Age \> 18 years
- Diagnosis of advanced RP using Fundus Photographs
- Clinical diagnosis of advanced retinal dystrophy
- Prior documented (if any) retinal electrophysiological evidence of rod-cone photoreceptor degeneration
- 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
- 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.
- Subjects who have undergone ocular surgery in the study eye within three months prior to Day 0.
- Presence of narrow iridocorneal angles contraindicating pupillary dilation in the study eye.
- Known sensitivity to any component of the study agent or medications planned for use in the peri-operative period.
- Subjects will be excluded if immunological studies show presence of neutralizing antibodies to AAV2 above 1:1000.
- 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 OCT, during the study period.
- Presence of vitreo-macular adhesion or traction, epiretinal membrane, macular pucker and macular hole, evident by ophthalmoscopy and/or by 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.
Key Trial Info
Start Date :
October 23 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2020
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT04919473
Start Date
October 23 2019
End Date
October 31 2020
Last Update
June 9 2021
Active Locations (1)
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1
JPM Rotary Club of Cuttack Eye Hospital and Research Institute
Cuttack, Odisha, India, 753014