Phase 2
N=125
NSAID Phase II for Non-central Involved Diabetic Macular Edema (DME)
Diabetic Macular Edema
Bottom Line
View on ClinicalTrials.gov: NCT01331005 ↗Enrolled (actual)
125
Serious AEs
22.4%
Results posted
Jan 2015
Primary outcome: Primary: Mean Change in Optical Coherence Tomography Measure Retinal Volume, mm3 — 0.02; -0.03 mm3
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- nepafenac 0.1% drops (Drug); Nepafenac Vehicle (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Jaeb Center for Health Research
- Primary completion
- Dec 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change in Optical Coherence Tomography Measure Retinal Volume, mm3 |
0.02; -0.03 | — |
| SECONDARY Mean Change in Visual Acuity |
-0.3; 0.2 | — |
| SECONDARY Change in OCT Central Subfield Thickness |
7; 9 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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.
- Successful completion of the run-in phase during which level of compliance is more than 80%
Study Eye Inclusion Criteria
- Best corrected E-ETDRS visual acuity letter score ≥74 (i.e.20/32 or better) within 8 days of randomization.
- 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 spectral domain OCT macular map that meet either of the following criteria:
- At least two non-central macular subfields with OCT thickness above threshold (average normal + 2 SD) from DRCR.net approved spectral domain OCT machines- see below.
- At least one non-central macular subfield with OCT thickness at least 15 μm above threshold (average normal + 2 SD) from DRCR.net approved spectral domain OCT machines-see DRCR.net procedures manual for threshold details.
- Central subfield thickness 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.
Study Eye Exclusion Criteria
- 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.
- Anticipated need to treat DME during the course of the study (Any DME treatment during the study should follow criteria in section 4.3).
- History of use of NSAID eye drops within the last 30 days or anticipated need for such drops during the study due to other ocular condition
- History of panretinal (scatter) photocoagulation (PRP) within 4 months prior to randomization
- Anticipated need for PRP in the 6 months following randomization
- Anticipated need for cataract extraction surgery in the study eye during the study period
- Lipid in the fovea (center of the macula)
- Hist
Data sourced from ClinicalTrials.gov (NCT01331005). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.