Effect and safety of the nutritional supplement Diamel Oral Solution® compared with placebo, in patients with diabetic macular edema without involvement of the macular center, treated or not with laser. Phase II

Catalysis Laboratories, SL.0 个研究点目标入组 160 人开始时间: 2024年7月31日最近更新: 2024年8月19日

试验速览

暂无简介。

研究类型: Interventional
分配方式: Randomized controlled trial. Masking: Double Blind. Control group: Placebo. Assignment: Parallel. Purpose: Treatment

•1. Type 1 or 2 diabetic patients with diabetic macular edema that does not affect the center of the macula, treated or not with laser.
•2. Patients between the ages of 20 and 69 years.
•3. Patients with glycosylated hemoglobin (HbA1c) < 9.0% at baseline.
•4. Patients who voluntarily give their written informed consent.

•1. Pregnant and/or breastfeeding patients.
•2. Patients with diabetic macular edema affecting the center of the macula.
•3. Patients with diabetic macular edema with vitreoretinal traction.
•4. Patients with refractive media opacity that makes ophthalmologic examination difficult (example: patients with cataracts or less than one year after surgery).
•5. Patients with a known history of hypersensitivity to another similar product or to one of the components of the test product formulation.
•6. Patients undergoing treatment with any other nutritional supplement.

发起方

Catalysis Laboratories, SL.