An observational study in Retinitis Pigmentosa, Retinal Disease and Retinal Degeneration, sponsored by Nanoscope Therapeutics Inc.. Enrolling by invitation at 1 site in India. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-25.
Sponsored by Nanoscope Therapeutics Inc. · Observational
This study "A Long-Term Follow-Up Study in Subjects Who Received an Adeno-Associated Viral Vector Serotype 2 Containing the Multi-Characteristic Opsin Gene (vMCO-I) Administered Via Intravitreal Injection" is an observational study and will be conducted following Good Clinical Practice (GCP)- International Conference on Harmonization (ICH) guidelines. Eligible subjects satisfying all inclusion and none of the exclusion criteria will be enrolled. All subject who completed the parent clinical study (NSCT/CT/18/01) will undergo safety and efficacy assessments up to 5 years post study drug injection
The observational study population comprises of individuals who received an Adeno-Associated Viral Vector Serotype 2 Containing the Multi-Characteristic Opsin Gene (vMCO-I) Administered Via Intravitreal Injection in a parent study.
Enrolled subjects will undergo safety and efficacy assessments for up to 5 years from the vMCO-I administration. At the visits, subjects will have safety and efficacy evaluations. Subjects will have a final visit at 60 months post study drug administration.
278 studies on the registry are indexed under Retinitis Pigmentosa; 72 are open to participants now.
This study's planned enrollment of 11 is below the median of 52 across 87 observational studies indexed under Retinitis Pigmentosa.
Browse Retinitis Pigmentosa studies →Nanoscope Therapeutics Inc. is the lead sponsor of 8 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
It is expected that a total of 11 study subjects from NSCT/CT/18/01 study will be enrolled. Subjects who meet all the inclusion criteria and for whom none of the exclusion criteria apply will be eligible for enrollment.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
This is a long-term follow-up observational study of participants who previously received 1.2E11gc/eye of vMCO-I No investigational product will be administered in this study.
Biological: Gene Therapy product:vMCO-I
This is a long-term follow-up observational study of participants who previously received 0.6E11gc/eye of vMCO-I No investigational product will be administered in this study.
Biological: Gene Therapy product:vMCO-I
Safety evaluation to monitor long term effects of previously injected vMCO-I in RP patients
Assessment of the long-term safety profile of a single intravitreal injection of vMCO-I
Assessments of Incidences, nature, and severity of treatment emergent adverse events (TEAEs), Serious Adverse Events (SAEs); intraocular inflammation graded through ocular exam; intraocular pressure and retinal anatomy
Time frame: 20 Months
Evaluation of the long-term efficacy of a single intravitreal injection of Multi-Characteristic Opsin (vMCO-I)
Assessment of treatment effect with the change from baseline in Freiburg Visual Acuity (quantitative LogMAR score)
Time frame: 20 Months
Assessment of the effect of vMCO-I on functional vision outcomes
Assessment of the treatment effect on the quality of Life with changes from baseline in activities of daily living using the National Eye Institute (NEI) Visual Function Questionnaire-25
Time frame: 20 Months
Assessment of the durability of vMCO-I induced gene reporter expression
Assessment of PK parameters including the Change in fundus fluorescence intensity of reporter (mCherry)
Time frame: 20 Months
Plan to share: Yes — The results of the clinical trial will be made available when the study is completed and results are analyzed. The results will be published on this site and be available to conference presentations and publications.
Time frame: Within a year from the long term monitoring data availability
Access criteria: IPD sharing access will be subject to data transfer agreement. IPD generated as part of this clinical study may be subject to patient confidentiality.
No publications or documents are linked to this record.
Started Jul 2023 (actual). Primary completion is estimated for May 2025, 22 months after the start.
Of 48 observational studies under Retinitis Pigmentosa, half reached primary completion within 76 months of starting (the median), counting those still running; a quarter within 28. This study's planned 22 months is below that.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
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Nanoscope Therapeutics Inc.