NSAID Phase II for Non-central Involved Diabetic Macular Edema (DME)
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|ClinicalTrials.gov Identifier: NCT01331005|
Recruitment Status : Completed
First Posted : April 7, 2011
Results First Posted : January 16, 2015
Last Update Posted : September 21, 2018
|Condition or disease||Intervention/treatment||Phase|
|Diabetic Macular Edema||Drug: nepafenac 0.1% drops Other: Nepafenac Vehicle||Phase 2|
There is strong evidence to indicate that prevention of non-central involved DME from progression into the central subfield of the macula is a good anatomic surrogate for preventing visual acuity loss. Furthermore, the prevalence of macular edema is estimated to be high among patients with diabetes, and it is likely that approximately 25% of non-central involved cases of DME extend into the central subfield of the macula within one year. Thus, if a relatively safe and economical treatment could be identified that reduced the progression of non-central involved edema to central-involved edema by at least 50%, this treatment could have a major public health impact.
There is also evidence that inflammation has a role in DME, and that a topical NSAID might have an effect on retinal edema. Topical NSAIDs are in current widespread clinical use and appear to be well tolerated and safe when administered chronically, making them a potentially attractive alternative treatment for DME in patients who would like to delay or avoid laser photocoagulation or intravitreal injections (for example, patients who are willing to use daily eye drops to avoid ocular procedures or patients for whom access to experienced retinal specialists to apply laser photocoagulation or other treatments is limited).
This phase II trial may provide proof of concept evidence that topical NSAID treatment can have a beneficial effect on DME and possibly prevent increases in retinal volume or progression of non central-involved DME into the central subfield of the macula. Furthermore, it could determine the correlation between OCT and fundus photographic documentation of progression of DME into the central subfield in this clinical trial setting. Since effective treatments, including laser photocoagulation and intravitreal injections, already exist for DME treatment, topical NSAIDs would have to demonstrate a substantial effect on DME progression in order to be of sufficient clinical interest for further investigation. If a beneficial effect is apparent in this trial, which utilizes a relatively small sample size and short follow-up period, results from this phase II study might be utilized in planning future phase III trials. These future phase III trials could definitively answer whether or not NSAIDs are an efficacious novel therapeutic approach to the treatment of DME or preventing the progression of DME from extending into the central subfield of the macula.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||125 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Phase II Evaluation of Topical Non-steroidal Anti-inflammatories in Eyes With Non Central Involved Diabetic Macular Edema|
|Study Start Date :||May 2011|
|Actual Primary Completion Date :||December 2013|
|Actual Study Completion Date :||December 2013|
Placebo Comparator: Placebo
Placebo will be given three times per day for one year
Other: Nepafenac Vehicle
Active Comparator: nepafenac 0.1% drops
Nepafenac drops will be given three times per day for one year
Drug: nepafenac 0.1% drops
One drop three times per day for one year
- Mean Change in Optical Coherence Tomography Measure Retinal Volume, mm3 [ Time Frame: From Baseline to 12 months ]
- Mean Change in Visual Acuity [ Time Frame: baseline to 12 months ]The 95% CI will be obtained in each treatment group and compared between treatment groups at 1 year. For eyes that have received treatment for diabetic macular edema(DME) before 1 year, visual acuity and optical coherence tomography (OCT) measurements obtained at time of failure will be used instead of measurements at 1 year.
- Change in OCT Central Subfield Thickness [ Time Frame: baseline to 12 months ]95% CI will be obtained in each treatment group and compared between treatment groups at 1 year. For eyes that have received treatment for DME before 1 year, visual acuity and OCT measurements obtained at time of failure will be used instead of measurements at 1 year.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01331005
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|Principal Investigator:||Scott M Friedman, MD||Florida Retina Consultants|