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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

Primary Purpose

Geographic Atrophy

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
OpRegen
Sponsored by
Genentech, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Geographic Atrophy focused on measuring Geographic Atrophy secondary to Age-related Macular Degeneration

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Retina-Vitreous Associates Medical GroupRecruiting
  • Retinal Consultants Medical GroupRecruiting
  • West Coast RetinaRecruiting
  • Cincinnati Eye InstituteRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

OpRegen

Arm Description

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

Outcomes

Primary Outcome Measures

Proportion of Patients With Subretinal Surgical Delivery of OpRegen to Target Regions
Incidence and Severity of Procedure-related Adverse Events at 3 Months Following Surgery

Secondary Outcome Measures

Proportion of Patients With Qualitative Improvement in Retinal Structure, as Determined by OCT Imaging Within 3 Months Following Surgery

Full Information

First Posted
November 15, 2022
Last Updated
October 19, 2023
Sponsor
Genentech, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05626114
Brief Title
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
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 24, 2023 (Actual)
Primary Completion Date
April 11, 2029 (Anticipated)
Study Completion Date
April 11, 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genentech, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Geographic Atrophy
Keywords
Geographic Atrophy secondary to Age-related Macular Degeneration

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
OpRegen
Arm Type
Experimental
Arm Description
OpRegen dose up to approximately 200,000 cells will be delivered into the subretinal space
Intervention Type
Biological
Intervention Name(s)
OpRegen
Intervention Description
OpRegen dose up to approximately 200,000 cells will be delivered into the subretinal space
Primary Outcome Measure Information:
Title
Proportion of Patients With Subretinal Surgical Delivery of OpRegen to Target Regions
Time Frame
3 months post surgery
Title
Incidence and Severity of Procedure-related Adverse Events at 3 Months Following Surgery
Time Frame
3 months post surgery
Secondary Outcome Measure Information:
Title
Proportion of Patients With Qualitative Improvement in Retinal Structure, as Determined by OCT Imaging Within 3 Months Following Surgery
Time Frame
3 months post surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Reference Study ID Number: GR44251 https://forpatients.roche.com/
Phone
888-662-6728 (U.S. Only)
Email
global-roche-genentech-trials@gene.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
Retina-Vitreous Associates Medical Group
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Individual Site Status
Recruiting
Facility Name
Retinal Consultants Medical Group
City
Sacramento
State/Province
California
ZIP/Postal Code
95825
Country
United States
Individual Site Status
Recruiting
Facility Name
West Coast Retina
City
San Francisco
State/Province
California
ZIP/Postal Code
94109-5520
Country
United States
Individual Site Status
Recruiting
Facility Name
Cincinnati Eye Institute
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

Learn more about this trial

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

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