A Randomised Multi-centre Placebo Controlled Trial of Fenofibrate for Treatment of Diabetic Macular Oedema with Economic Evaluation (FORTE Study)
Recruiting
- Conditions
- Diabetic Macular OedemaEye - Diseases / disorders of the eyeMetabolic and Endocrine - Diabetes
- Registration Number
- ACTRN12618000592246
- Lead Sponsor
- niversity of Sydney
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 392
Inclusion Criteria
1. Male or Female patients >= 25 years at the time of consent.
2. Diagnosed with type 2 diabetes
3. Diagnosed with DME on SD-OCT.
Exclusion Criteria
1. Current use of fenofibrate
2. Pregnancy, or intention to become pregnant within the trial period
3. Contraindication to fenofibrate use.
4. Other causes of macular oedema including epiretinal membrane, vitreomacular traction, retinal vein occlusion, AMD, cataract surgery in the last 6 months.
5. Previous treatment for DME in the prior 12 months including focal/grid laser, anti-VEGF injections, intravitreal triamcinolone injections.
6. Active retinal neovascularisation requiring pan retinal photocoagulation laser therapy.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method