What side effects are associated with this type of intervention?

Common treatments for Age-Related Macular Degeneration (AMD) include anti-VEGF injections, photodynamic therapy, and laser therapy. Anti-VEGF injections, such as ranibizumab and aflibercept, can cause side effects like eye pain, increased intraocular pressure, and inflammation. Photodynamic therapy may lead to temporary vision changes, photosensitivity, and eye pain. Laser therapy can result in scarring and potential vision loss in treated areas. Regenerative therapies like OpRegen, which involve subretinal surgical delivery of retinal cells, are being studied for their safety and efficacy, with potential side effects including surgical complications, inflammation, and retinal detachment.

What prior FDA approvals exist?

The FDA has approved several treatments for Age-Related Macular Degeneration (AMD), primarily focusing on anti-VEGF (vascular endothelial growth factor) therapies such as ranibizumab (Lucentis), aflibercept (Eylea), and bevacizumab (Avastin). These treatments work by inhibiting abnormal blood vessel growth and leakage in the retina. While these therapies are effective for the neovascular (wet) form of AMD, regenerative therapies like OpRegen, which aim to replace damaged retinal cells, represent a novel approach. OpRegen is currently being studied for its potential to treat geographic atrophy secondary to AMD, a condition for which there are limited treatment options. This trial aims to evaluate the safety and efficacy of subretinal surgical delivery of OpRegen, a cell-based therapy designed to regenerate retinal pigment epithelial cells.

What other types of research exist?

Promising novel alternatives to OpRegen for AMD patients include: 1) Gene therapy approaches such as RGX-314, which delivers a gene encoding for an anti-VEGF protein to reduce retinal fluid and improve vision. 2) Stem cell-based therapies like jCell (human retinal progenitor cells) that aim to replace damaged retinal cells. 3) Antisense oligonucleotide therapies targeting specific genetic mutations associated with AMD. 4) Novel pharmacological treatments like Faricimab, a bispecific antibody targeting both VEGF and Ang-2, which has shown promising results in clinical trials.

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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 up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing OpRegen, a cell injection treatment, in patients with severe vision loss due to age-related macular degeneration. The goal is to see if injecting these cells under the retina can help repair or support damaged eye cells.

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Age-Related Macular Degeneration (AMD) include anti-VEGF (vascular endothelial growth factor) injections, laser therapy, and regenerative therapies like OpRegen. Anti-VEGF injections work by inhibiting the growth of abnormal blood vessels in the retina, reducing fluid leakage and vision loss. Laser therapy targets and destroys these abnormal vessels to prevent further damage. Regenerative therapies, such as OpRegen, involve the transplantation of retinal pigment epithelial (RPE) cells derived from stem cells to replace damaged cells and restore retinal function. These treatments are crucial for AMD patients as they aim to preserve and improve vision, thereby enhancing the quality of life and reducing the risk of severe vision impairment.