Laser-Ranibizumab-Triamcinolone for Diabetic Macular Edema

(LRT for DME Trial)

Recruiting in Palo Alto (17 mi)

+49 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Jaeb Center for Health Research

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

The purpose of the study is to find out which is a better treatment for diabetic macular edema (DME): laser alone, laser combined with an intravitreal injection of triamcinolone, laser combined with an intravitreal injection of ranibizumab, or intravitreal injection of ranibizumab alone. At the present time, it is not known whether intravitreal steroid or anti-vascular endothelial growth factor (anti-VEGF) injections, with or without laser treatment, are better than just laser by itself. It is possible that one or both of the types of injections, with or without laser treatment, will improve vision more often than will laser without injections. However, even if better vision outcomes are seen with injections, side effects may be more of a problem with the injections than with laser. Therefore, this study is conducted to find out whether the benefits of the injections will outweigh the risks.

Research Team

Michael J. Elman, M.D.

Principal Investigator

Elman Retina Group, PA

Eligibility Criteria

Inclusion Criteria

General Inclusion Criteria

Age >= 18 years

Diagnosis of diabetes mellitus (type 1 or type 2)

Treatment Details

Interventions

• Laser (Procedure)
• Ranibizumab (Monoclonal Antibodies)
• Triamcinolone Acetonide (Corticosteroid)

Participant Groups

Group I: 4 mg Triamcinolone plus laser Experimental Treatment 1 Intervention

Group II: 0.5mg Ranibizumab plus laser Experimental Treatment 1 Intervention

Group III: 0.5 mg Ranibizumab plus deferred laser Experimental Treatment 1 Intervention

Group IV: Sham plus laser Active Control 1 Intervention

Who Is Running the Clinical Trial?

Jaeb Center for Health Research

Lead Sponsor

Trials

162

Recruited

36,200+

Dr. Roy W. Beck

Jaeb Center for Health Research

Chief Medical Officer since 2022

MD, PhD

Adam Glassman

Jaeb Center for Health Research

Chief Executive Officer since 2023

PhD in Biostatistics

Allergan

Industry Sponsor

Trials

782

Recruited

277,000+

Brent Saunders

Allergan

Chief Executive Officer since 2015

JD and MBA from Temple University

Dr. David Nicholson

Allergan

Chief Medical Officer since 2015

MD from Harvard Medical School

Genentech, Inc.

Industry Sponsor

Trials

1,578

Recruited

569,000+

Ashley Magargee

Genentech, Inc.

Chief Executive Officer since 2024

MBA from Harvard University, BA from Princeton University

Levi Garraway

Genentech, Inc.

Chief Medical Officer since 2021

MD, PhD

National Eye Institute (NEI)

Collaborator

Trials

572

Recruited

1,320,000+

Dr. Michael F. Chiang

National Eye Institute (NEI)

Chief Executive Officer since 2020

MD from Harvard Medical School

Dr. Richard Lee

National Eye Institute (NEI)

Chief Medical Officer since 2021

MD, PhD from Harvard Medical School