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

Phase 2

• Conditions: Diabetic Macular Edema

• Registration Number: RPCEC00000447
• Lead Sponsor: Catalysis Laboratories, SL.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-31
• Last Update Posted: 19 August 2024
• Study Completion: 2027-04-30
• Results First Posted: 2027-10-29

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified