A Study to Optimize Subretinal Surgical Delivery and to Evaluate Safety and Activity of Opregen in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration

Geographic Atrophy Clinical Trial

Official title:

A Phase IIa, Multicenter, Open-Label, Single-Arm Study To Optimize Subretinal Surgical Delivery And To Evaluate Safety And Activity Of Opregen In Patients With Geographic Atrophy Secondary to Age-Related Macular Degeneration

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05626114
• Other study ID #: GR44251
• Status: Recruiting
• Phase: Phase 2
• Start date: March 24, 2023
• Est. completion date: April 11, 2029

Study information

• Verified date: June 2024
• Source: Genentech, Inc.
• Contact: Reference Study ID Number: GR44251 https://forpatients.roche.com
• Phone: 888-662-6728 (U.S. Only)
• Email: global-roche-genentech-trials[@]gene.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will evaluate the success and safety of subretinal surgical delivery as well as the preliminary activity of OpRegen in participants with geographic atrophy (GA) secondary to age-related macular degeneration (AMD). All endpoints are assessed for the study eye unless otherwise indicated.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: April 11, 2029
• Est. primary completion date: April 11, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• Ability to undergo a vitreoretinal surgical procedure under monitored anesthesia care

• Diagnosis of GA secondary to AMD

• BCVA score >/= 35 letters and </= 60 letters in the study eye as assessed by ETDRS

• Pseudophakic (study eye)

Exclusion Criteria:

• Pregnancy or breastfeeding

• History of cognitive impairment or dementia

• Any type of systemic disease or its treatment, in the opinion of the investigator, including any medical conditions that could be expected to progress, recur, or change to such an extent that it may bias the assessment of the clinical status of the patient to a significant degree or put the patient at special risk

Ocular Exclusion Criteria for Study Eye:

• Any current or history of ocular disease other than GA that may confound assessment of the macula

• History of retinal detachment

• History of vitrectomy, glaucoma-filtering surgery, or corneal transplant

• Uncontrolled glaucoma or advanced glaucoma

• Any cataract surgery or intraocular surgery within 3 months prior to subretinal surgical delivery of OpRegen

• History of other ocular or intraocular conditions that contraindicate the use of an investigational drug or may affect interpretation of the study results or may render the patient at high risk for treatment complications

Related Conditions & MeSH terms

• Atrophy
• Geographic Atrophy
• Macular Degeneration

Intervention

Biological:
• OpRegen
OpRegen dose up to approximately 200,000 cells will be delivered into the subretinal space

Locations

Country	Name	City	State
United States	Retina-Vitreous Associates Medical Group	Beverly Hills	California
United States	Cincinnati Eye Institute	Cincinnati	Ohio
United States	Mid Atlantic Retina	Philadelphia	Pennsylvania
United States	Retinal Consultants Medical Group	Sacramento	California
United States	West Coast Retina	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of Patients With Subretinal Surgical Delivery of OpRegen to Target Regions		3 months post surgery
Primary	Incidence and Severity of Procedure-related Adverse Events at 3 Months Following Surgery		3 months post surgery
Secondary	Proportion of Patients With Qualitative Improvement in Retinal Structure, as Determined by OCT Imaging Within 3 Months Following Surgery		3 months post surgery