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

Sponsor

Genentech, Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05626114

Collaborator

(none)

Enrollment

Location

Arm

79.6

Anticipated Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Geographic Atrophy	Biological: OpRegen	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Jan 27, 2023

Anticipated Primary Completion Date :

Sep 15, 2029

Anticipated Study Completion Date :

Sep 15, 2029

Arms and Interventions

Arm	Intervention/Treatment
Experimental: OpRegen OpRegen dose up to approximately 200,000 cells will be delivered into the subretinal space	Biological: OpRegen OpRegen dose up to approximately 200,000 cells will be delivered into the subretinal space

Arm

Intervention/Treatment

Experimental: OpRegen

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

Biological: OpRegen

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

Outcome Measures

Primary Outcome Measures

Proportion of patients with subretinal surgical delivery of OpRegen to target regions [3 months post surgery]
Incidence and severity of procedure-related adverse events at 3 months following surgery [3 months post surgery]

Secondary Outcome Measures

• Proportion of patients with qualitative improvement in retinal structure, as determined by OCT imaging within 3 months following surgery [3 months post surgery]

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cincinnati Eye Institute	Cincinnati	Ohio	United States	45242

Sponsors and Collaborators

Genentech, Inc.

Investigators

Study Director: Clinical Trials, Hoffmann-La Roche

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Genentech, Inc.

ClinicalTrials.gov Identifier:

NCT05626114

Other Study ID Numbers:

GR44251

First Posted:

Nov 23, 2022

Last Update Posted:

Jan 17, 2023

Last Verified:

Jan 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Genentech, Inc.

Geographic Atrophy secondary to Age-related Macular Degeneration

Additional relevant MeSH terms:

Macular Degeneration

Geographic Atrophy

Atrophy

Study Results

No Results Posted as of Jan 17, 2023