A Phase 2 Clinical Trial on the Use of Cibinetide for the Treatment of Diabetic Macular Edema.
A nine-patient open-label diabetic macular edema study found no mean improvement in visual acuity, retinal thickness, retinal sensitivity, or tear production.
A nine-patient open-label diabetic macular edema study found no mean improvement in visual acuity, retinal thickness, retinal sensitivity, or tear production.
Research summary
Nine participants entered this phase 2 study and eight completed it. At 12 weeks there was no mean improvement in best-corrected visual acuity, central retinal thickness, central retinal sensitivity, or tear production. A visual-function questionnaire score improved and some individual participants had changes in other exploratory measures. No serious adverse events or anti-cibinetide antibodies were reported.
Limitations and interpretation
The study was uncontrolled, very small, and descriptive. Exploratory questionnaire and individual-patient signals do not override the null mean ocular endpoints. The paper lists EudraCT 2015-001940-12 and ISRCTN16962255. A corresponding nine-participant diabetic macular oedema registry entry, NCT06626971, is terminated because study drug expired with no replacement; termination should not be misrepresented as proof of toxicity.
Source
Lois N, Gardner E, McFarland M, et al. A Phase 2 Clinical Trial on the Use of Cibinetide for the Treatment of Diabetic Macular Edema. Journal of clinical medicine. 2020 Jul 14. DOI: 10.3390/jcm9072225. PMID: 32674280.
Original PubMed record. Publisher DOI. Sources reviewed October 15, 2026. This page is an educational summary, not a reproduction of the full publication.
Connected compound
ARA-290 / cibinetide monograph. Educational information only; no treatment or personal-use recommendations.
Keywords
For research use only. Not medical advice.