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Fenofibrate · 1 trial · 1 indication
Defined as * 2 or more step worsening on Early Treatment Diabetic Retinopathy Study (ETDRS) diabetic retinopathy severity on fundus photographs. * Development of neovascularization within the 7-modified ETDRS fields on fluorescein angiography. * Intraocular procedure undertaken to treat diabetic retinopathy including panretinal photocoagulation, intraocular anti-vascular endothelial growth factor, corticosteroid, or vitrectomy.
| Arm | Type | Description |
|---|---|---|
| Fenofibrate 160-mg | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Fenofibrate | DRUG | Participants begin with a dose of either 160mg or 54mg fenofibrate, based on eGFR value at screening, taken once daily with food. The dose may be adjusted during follow-up based on protocol guidelines. |
| Placebo | OTHER | Participants begin with a dose of either 160mg or 54mg placebo, based on eGFR value at screening, taken once daily with food. The dose may be adjusted during follow-up based on protocol guidelines. |
Key Inclusion Criteria * Age ≥18 years and \< 80 years. * Type 1 or type 2 diabetes. * At least one eye with the following: * Mild to moderately severe NPDR (defined by ETDRS DR severity level 35 to 47), confirmed by central Reading Center grading of fundus photographs. * Best-corrected E-ETDR...
Fenofibrate is being investigated for the prevention of diabetic retinopathy worsening. It is a small molecule in Phase 3 clinical development for this ophthalmologic condition. The drug is being studied in a randomized, double-blind, placebo-controlled trial to assess its effect on preventing the progression of diabetic retinopathy.
Fenofibrate is a small molecule that works by activating peroxisome proliferator-activated receptor alpha (PPAR-alpha). This mechanism is being studied for its potential to prevent the worsening of diabetic retinopathy. The drug is currently in Phase 3 clinical trials for this indication.
Fenofibrate is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company is conducting a Phase 3 clinical trial for the drug in diabetic retinopathy. This trial is active but not recruiting participants.
Fenofibrate is in Phase 3 clinical development for diabetic retinopathy. It is an investigational drug and has not been approved for this indication. The ongoing Phase 3 trial is a randomized, double-blind, placebo-controlled study with an enrollment of 563 participants.
Fenofibrate is being studied in a Phase 3 clinical trial with the identifier NCT04661358, titled 'Fenofibrate for Prevention of DR Worsening'. This trial is active but not recruiting, with 563 participants enrolled in the United States. The study is randomized, double-blind, and placebo-controlled.
Fenofibrate is a well-known small molecule drug, and this specific development program by Roche is focused on diabetic retinopathy. The drug is being evaluated in a Phase 3 trial to prevent the worsening of diabetic retinopathy, and it is being studied in a placebo-controlled setting.