A Phase 1/2a Multi-Center, Dose-Escalation Study to Evaluate the Safety & Efficacy of Eyecyte-RPE™ When Administered as a Single-dose Subretinal Injection in Subjects With Geographic Atrophy Secondary to Dry Age-related Macular Degeneration

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY

The goal of this clinical study is to evaluate the safety and efficacy of novel stem cell formulation in patients having Geographic Atrophy (GA) Secondary to Dry Age-related Macular Degeneration (d-AMD). The main questions it aims to answer are: * Safety and tolerability of the novel stem cell formulation * Potential efficacy of the novel stem cell formulation Participants will receive a single subretinal injection in their study eye and followed up for safety. This is an India only study and the product is developed indigenously.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Maximum Age: 100
Healthy Volunteers: f
View:

• Men and women ≥ 50 years of age at Screening.

• Diagnosis of Geographic Atrophy secondary to d-AMD

• Have Best Corrected Visual Acuity (BCVA) equal to or less than 20/200 Snellen (ETDRS letter score ≤ 35) in the study eye at screening.

∙ Phase 1 ≤ 20/200 and

‣ Phase 2a ≥ 20/64 (ETDRS letter score 60) in the study eye at Screening.

• Vision in the unoperated eye must be better or equal to vision in the study eye.

• Willing, committed, and able to return for ALL clinic visits and complete all study related procedures.

• Be medically suitable to undergo anesthesia, vitrectomy and subretinal injection in the opinion of the Investigator.

• Be medically suitable for immunosuppression therapy in accordance with the requirements of this protocol in the opinion of the Investigator.

• Able to read (or if unable to read due to visual impairment, be read to verbatim by the person administering the informed consent or a family member) and understand, and willing to sign the informed consent form (ICF)

• Willing to provide signed Informed Consent prior to any procedures being performed at Visit 1, Screening.

⁃ Negative for HIV, HbsAg, HCV, TB

⁃ The GA lesion must meet the following criteria as determined by the central reading center's assessment of Fundus Autofluorescence (FAF) imaging at screening:

• Total GA area must be ≥ 1.25 and ≤ 17.5 mm2 (0.5 and 7 disk areas \[DA\] respectively)

∙ The entire GA lesion must be completely visualized on the macula centered image and must be able to be imaged in its entirety and not contiguous with any areas of peripapillary atrophy.

∙ At least one of the lesions has to be sub-foveal.

Locations
Other Locations
India
All India Institute of Medical Sciences
RECRUITING
Delhi
L V Prasad Eye Institute
RECRUITING
Hyderabad
Shri Ganapati Netralaya
RECRUITING
Jālna
Contact Information
Primary
Dr Jogin Desai, MBBS
jogin.desai@eyestem.com
+91 7676235515
Backup
Dr Rajani Battu, MBBS,MS,DNB,FRCS(Edin),PhD
rajani.battu@eyestem.com
+91 7676235515
Time Frame
Start Date: 2024-06-04
Estimated Completion Date: 2030-12
Participants
Target number of participants: 54
Treatments
Experimental: Dose Level 1-Cohort 1
Subjects who are allocated to Dose Level 1-Cohort 1 will receive 100,000 cells of Eyecyte-RPE™
Experimental: Dose Level 2-Cohort 2
Subjects who are allocated to Dose Level 2-Cohort 2 will receive 200,000 cells of Eyecyte-RPE™
Experimental: Dose Level 3-Cohort 3
Subjects who are allocated to Dose Level 3-Cohort 3 will receive 300,000 cells of Eyecyte-RPE™
Sponsors
Leads: Eyestem Research Pvt. Ltd.

This content was sourced from clinicaltrials.gov