Metformin Effect in Optical Coherence Tomography Prognosis Biomarkers and Disease Progression in Intermediate Age-related Macular Degeneration
Key facts
- Where
- Lisbon, PortugáliaSee the site
- Phase
- 2. fázis
Where in Portugália
- Unidade Local De Saude De Sao Jose E.P.E.Lisbon, PortugáliaToborzás még nem indult
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Unidade Local De Saude De Sao Jose E.P.E.
- Trial code
- EU 2025-522990-12-00
- Record updated
- 2026. november 6.
- Original description
To assess the effect of Metformin in preventing the progression of intermediate AMD for the advanced stage on top of standard-of-care treatment.Read full original descriptionShow less
To assess the effect of Metformin in preventing the progression of intermediate AMD for the advanced stage on top of standard-of-care treatment.
Inclusion: Subjects of both genders over 55 years old with intermediate AMD, more specifically: Eyes presenting large drusen (≥125 µm) or with pigmentary abnormalities associated with at least one medium drusen (≥63 µm and <125 µm); And at least one high-risk prognosis biomarker in OCT (presence of incomplete retinal pigment epithelial and outer retinal atrophy (iRORA); ellipsoid zone (EZ) disruption; presence of hyperreflective foci; neovascular lesion in the fellow eye). Only one eye per patient will be considered, even if both eyes are potentially eligible. If both eyes are eligible, the study eye is selected at random, using a documented procedure, before randomisation; Ability to provide informed consent and comply with study procedures.
Exclusion: Late AMD (cRORA or MNV) or any evidence of accumulation of extracellular fluid, haemorrhage, exudates, or fibrosis in the study eye; Any history of retinal surgery including laser treatment, of retinal vascular occlusion, history of anti-VEGF treatment in the studied eye or any signs or history of hereditary retinal or macular dystrophy; History of metformin intake; Contraindications listed in section 4.3 of the SmPC (hypersensitivity to metformin or excipients; acute metabolic acidosis; diabetic pre-coma; acute conditions that may alter renal function; diseases that may cause tissue hypoxia; hepatic insufficiency, acute alcohol intoxication, alcoholism) or known mitochondrial disease; Current use of medicinal products with potential retinal toxicity (hydroxychloroquine/chloroquine, pentosan polysulfate sodium, tamoxifen, MEK inhibitors); Diabetes: previous diagnosis, current glucose-lowering treatment, HbA1c ≥ 6.5% or fasting plasma glucose ≥ 126 mg/dL at screening (prediabetes is not an exclusion criterion); Current use of any glucose-lowering medicinal product for any indication, including GLP-1 receptor agonists and SGLT2 inhibitors; Insufficient quality of SD-OCT (Spectral Domain Optical Coherence Tomography) images; Participation in another interventional clinical trial; Refractive error ≥±6D; Estimated glomerular filtration rate < 60 mL/min/1.73m².