NSAID Phase II for Non-central Involved Diabetic Macular Edema (DME)

NCT01331005 | Completed Phase 2 Results DMC

• 3 other identifiers: DRCR.net Protocol RU10EY018817-03U10EY014231-09
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 32

Brief Summary

This study is being conducted to assess the effects of topical nonsteroidal anti-inflammatories (NSAIDs) on macular retinal volume compared with placebo in eyes with non-central diabetic macular edema (DME). A secondary objective of this study is to assess the effects of topical NSAIDs on central subfield thickness and to compare the progression of non-central DME to central DME as determined by optical coherence tomography (OCT) and stereoscopic fundus photographs. Furthermore, this phase II study is being conducted (1) to determine whether the conduct of a phase III trial has merit based on an anatomic outcome, (2) to estimate recruitment potential of a phase III investigation, and (3) to provide information on outcome measures needed to design a phase III trial. The study is not designed to establish the efficacy of NSAIDs in the treatment of non- central DME.

Conditions

Diabetic Macular Edema

Keywords

Macular Edema; Non steroidal anti-inflammatories

Outcome Measures

Primary Outcomes (1)

• Mean Change in Optical Coherence Tomography Measure Retinal Volume, mm3

  From Baseline to 12 months

Secondary Outcomes (2)

• Mean Change in Visual Acuity

  baseline to 12 months

• Change in OCT Central Subfield Thickness

  baseline to 12 months

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo will be given three times per day for one year

Other: Nepafenac Vehicle

nepafenac 0.1% drops

ACTIVE COMPARATOR

Nepafenac drops will be given three times per day for one year

Drug: nepafenac 0.1% drops

Interventions

nepafenac 0.1% drops DRUG

One drop three times per day for one year

nepafenac 0.1% drops

Nepafenac Vehicle OTHER

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>18 years
• Type 1 or type 2 diabetes
• Only one study eye per subject may be enrolled. The study eye must meet the following:
• Best corrected E-ETDRS visual acuity letter score ≥ 74 (i.e., 20/32 or better) within 8 days of enrollment.
• On clinical exam, definite retinal thickening due to DME within 3000 μm of the center of the macula but not involving the central subfield.
• Thickened non-central macular subfields on DRCR.net approved spectral domain OCT macular map.
• Central subfield thickness within threshold definition for normal central subfield thickness on DRCR.net approved spectral domain OCT machine.
• No focal/grid laser within the last 6 months or other treatment for DME within the last 4 months.
• No anticipated need to treat DME during the course of the study, unless the eye meets the criteria for treatment (Central subfield retinal thickness increases to 310 μm or more in spectral domain OCT machine from baseline).
• Diagnosis of diabetes mellitus (type 1 or type 2). Any one of the following will be considered to be sufficient evidence that diabetes is present:
• Current regular use of insulin for the treatment of diabetes.
• Current regular use of oral anti-hyperglycemia agents for the treatment of diabetes.
• Documented diabetes by American Diabetes Association and/or the World Health Organization criteria.
• At least one eye meets the study eye criteria.
• Able and willing to provide informed consent.

You may not qualify if:

• A condition that, in the opinion of the investigator, would preclude participation in the study (e.g., unstable medical status including blood pressure, cardiovascular disease, and glycemic control).
• Subjects in poor glycemic control who, within the last 4 months, initiated intensive insulin treatment (a pump or multiple daily injections) or plan to do so in the next 4 months should not be enrolled.
• Use of systemic corticosteroids or anti-VEGF therapy.
• Current use of prescription systemic NSAIDs.
• History of auto-immune diseases such as rheumatoid arthritis.
• Participation in an investigational trial that involved treatment with any drug within 30 days of randomization that has not received regulatory approval at the time of study entry.
• Note: study participants cannot receive another investigational drug while participating in the study.
• Known allergy to any component of the study drug.
• Blood pressure \> 180/110 mmHg (systolic above 180 or diastolic above 110 mmHg)
• If blood pressure is brought below 180/110 by anti-hypertensive treatment, study participant can become eligible.
• Participant is expecting to move out of the area of the clinical center to an area not covered by another clinical center during the 12 months of the study.
• For women of child-bearing potential: pregnant or lactating or intending to become pregnant within the next 12 months.
• Women who are potential study participants should be questioned about the potential for pregnancy. Investigator judgment is used to determine when a pregnancy test is needed.
• History of focal/grid laser within the last 6 months or other treatment for DME within the last 4 months
• Note: Throughout the study, the distribution of subjects with prior treatment for DME will be evaluated, and eligibility criteria may be tailored to add balance between subjects with prior treatment and subjects without prior treatment for DME.

Sponsors & Collaborators

• Jaeb Center for Health Research: lead
• National Eye Institute (NEI): collaborator

Study Sites (32)

Loma Linda University Health Care, Dept. of Ophthalmology

Loma Linda, California, 92354, United States

Location

Southern California Desert Retina Consultants, MC

Palm Springs, California, 92262, United States

Location

California Retina Consultants

Santa Barbara, California, 93103, United States

Location

Bay Area Retina Associates

Walnut Creek, California, 94598, United States

Location

Retinal Consultants of Southern California Medical Group, Inc.

Westlake Village, California, 91361, United States

Location

Retina Consultants of Southwest Florida

Fort Myers, Florida, 33912, United States

Location

Central Florida Retina Institute

Lakeland, Florida, 33805, United States

Location

Southeast Retina Center, P.C.

Augusta, Georgia, 30909, United States

Location

Retina Associates of Hawaii, Inc.

Honolulu, Hawaii, 96813, United States

Location

Raj K. Maturi, M.D., P.C.

Indianapolis, Indiana, 46290, United States

Location

American Eye Institute

New Albany, Indiana, 47150, United States

Location

Wolfe Eye Clinic

West Des Moines, Iowa, 50266, United States

Location

Retina and Vitreous Associates of Kentucky

Lexington, Kentucky, 40509-1802, United States

Location

Paducah Retinal Center

Paducah, Kentucky, 42001, United States

Location

Elman Retina Group, P.A.

Baltimore, Maryland, 21237, United States

Location

Joslin Diabetes Center

Boston, Massachusetts, 02215, United States

Location

Henry Ford Health System, Dept of Ophthalmology and Eye Care Services

Detroit, Michigan, 48202, United States

Location

Vitreo-Retinal Associates

Grand Rapids, Michigan, 49525, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Eyesight Ophthalmic Services, PA

Portsmouth, New Hampshire, 03801, United States

Location

Eye Care for the Adirondacks

Plattsburgh, New York, 12901, United States

Location

Retina-Vitreous Surgeons of Central New York, PC

Syracuse, New York, 13224, United States

Location

Charlotte Eye Ear Nose and Throat Assoc, PA

Charlotte, North Carolina, 28210, United States

Location

Retina Associates of Cleveland, Inc.

Beachwood, Ohio, 44122, United States

Location

Retina Northwest, PC

Portland, Oregon, 97210, United States

Location

Family Eye Group

Lancaster, Pennsylvania, 17601-2644, United States

Location

Southeastern Retina Associates, PC

Kingsport, Tennessee, 37660, United States

Location

Southeastern Retina Associates, P.C.

Knoxville, Tennessee, 37909, United States

Location

Texas Retina Associates

Lubbock, Texas, 79424, United States

Location

Retinal Consultants of San Antonio

San Antonio, Texas, 78240, United States

Location

University of Washington Medical Center

Seattle, Washington, 98195, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (1)

• Friedman SM, Almukhtar TH, Baker CW, Glassman AR, Elman MJ, Bressler NM, Maker MP, Jampol LM, Melia M; Diabetic Retinopathy Clinical Research Network. Topical nepafenec in eyes with noncentral diabetic macular edema. Retina. 2015 May;35(5):944-56. doi: 10.1097/IAE.0000000000000403.

  PMID: 25602634 RESULT

MeSH Terms

Conditions

Macular Edema

Interventions

nepafenac

Condition Hierarchy (Ancestors)

Macular Degeneration; Retinal Degeneration; Retinal Diseases; Eye Diseases

Results Point of Contact

• Title: Adam Glassman
• Organization: Jaeb Center for Health Research

drcrnet@jaeb.org

813-975-8690

Study Officials

• Scott M Friedman, MD

  Florida Retina Consultants

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2011
• First Posted: April 7, 2011
• Study Start: May 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: March 10, 2025
• Results First Posted: January 16, 2015

Record last verified: 2025-02

Locations

US (32)