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Stem Cell Therapy

OpRegen for Age-Related Macular Degeneration

Phase 2
Recruiting
Research Sponsored by Genentech, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months post surgery
Awards & highlights

Study Summary

This trial will look at a new treatment for AMD, evaluating its safety and effectiveness in people with GA. All results will be from their study eye.

Who is the study for?
This trial is for individuals with geographic atrophy due to age-related macular degeneration who can undergo eye surgery under anesthesia. They should have a certain level of vision in the affected eye and must not be pregnant, breastfeeding, or have cognitive impairments or unstable systemic diseases.Check my eligibility
What is being tested?
The study tests the effectiveness and safety of OpRegen when delivered through subretinal surgery in patients with geographic atrophy secondary to AMD. It aims to optimize surgical procedures and assess how well OpRegen works on the treated eye.See study design
What are the potential side effects?
While specific side effects are not listed here, potential risks may include those associated with vitreoretinal surgery such as infection, bleeding, retinal detachment, inflammation inside the eye (endophthalmitis), and changes in vision.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months post surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months post surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence and Severity of Procedure-related Adverse Events at 3 Months Following Surgery
Proportion of Patients With Subretinal Surgical Delivery of OpRegen to Target Regions
Secondary outcome measures
Proportion of Patients With Qualitative Improvement in Retinal Structure, as Determined by OCT Imaging Within 3 Months Following Surgery

Trial Design

1Treatment groups
Experimental Treatment
Group I: OpRegenExperimental Treatment1 Intervention
OpRegen dose up to approximately 200,000 cells will be delivered into the subretinal space

Find a Location

Who is running the clinical trial?

Genentech, Inc.Lead Sponsor
1,540 Previous Clinical Trials
567,869 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,201 Previous Clinical Trials
888,880 Total Patients Enrolled

Media Library

OpRegen (Stem Cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05626114 — Phase 2
Age-Related Macular Degeneration Research Study Groups: OpRegen

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA sanctioned OpRegen for public use?

"Data collected from Phase 2 of the OpRegen trial indicates a reasonable degree of safety, awarding this medication an overall score of 2. However, there is no clinical evidence to suggest efficacy at this time."

Answered by AI

What is the maximum number of participants being accepted for this trial?

"Affirmative, the details on clinicaltrials.gov demonstrate that this medical trial is actively seeking out participants. This study was first posted to the site on January 27th 2023 and its last update occurred 12 days later. 60 patients are sought from a single clinic for participation in this experiment."

Answered by AI

Are new participants being accepted for this study currently?

"Affirmative, clinicaltrials.gov records indicate that recruitment for this medical investigation is actively underway. This trial was first posted on January 27th 2023 and its information was last updated on the 12th of the same month. The research team requires 60 participants at a single location to take part in their project."

Answered by AI

Who else is applying?

What state do they live in?
California
Mississippi
What site did they apply to?
Retina-Vitreous Associates Medical Group
Cincinnati Eye Institute
Retinal Consultants Medical Group
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
1

Why did patients apply to this trial?

I have been receiving Eylea injections for wet AMD but have now developed Geographic Atrophy and my eyesight seems to be fading quite rapidly.
PatientReceived 2+ prior treatments
I have had injections in the right eye and it is stable. I was motivated by reading studies of experimental procedures and I feel that I will benefit by the DNA study. I will be very happy if I can read music again to play piano and organ.
PatientReceived no prior treatments

What questions have other patients asked about this trial?

How long do the screening visits take? How often will I need to drive to Sacramento from home in Cameron Park?
PatientReceived no prior treatments
How much time would I need to spend in the study city? Are there other trials that may be halpful and available to me?
PatientReceived no prior treatments

How responsive is this trial?

Average response time
  • < 2 Days
Typically responds via
Phone Call
Most responsive sites:
  1. Retinal Consultants Medical Group: < 24 hours
Recent research and studies
clinicaltrials.govStudy
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
2023. "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". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05626114.
All > Age Related Macular Degeneration > Geographic Atrophy
~40 spots leftby Apr 2029
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