A Phase 2 Clinical Trial on the Use of Cibinetide for the Treatment of Diabetic Macular Edema.
Lois. Noemi N; Gardner. Evie E; McFarland. Margaret M; Armstrong. David D; McNally. Christine C; Lavery. Nuala Jane NJ; Campbell. Christina C; Kirk. Rita I RI; Bajorunas. Daiva D; Dunne. Ann A; Cerami. Anthony A; Brines. Michael M
Key Findings
- No significant change in best‑corrected visual acuity or central retinal thickness after 12 weeks.
- Quality‑of‑life scores (NEI VFQ‑25) improved modestly, and a few subjects showed better tear production, blood‑sugar control, and albuminuria.
- The 12‑week regimen was well‑tolerated with no serious side effects or anti‑cibinetide antibodies.
Practical Outcomes
- For most biohackers, cibinetide does not currently offer a reliable way to treat diabetic eye swelling or boost vision. The safety data are reassuring, but the lack of clear efficacy means it isn’t ready for self‑experimentation. If you have diabetes and are interested in kidney or metabolic markers, the occasional modest improvements observed are too inconsistent to base a protocol on.
Summary
A small Phase 2 study gave people with diabetic eye swelling (diabetic macular edema) a daily injection of the peptide cibinetide (also called ara‑290) for 12 weeks. The drug was safe, but it didn’t noticeably improve vision, retinal thickness, or eye sensitivity overall. Some participants reported feeling better in vision‑related quality‑of‑life surveys and showed modest improvements in eye fluid levels, blood sugar control, and kidney markers, but these effects were not consistent.
Abstract
Evaluating the effects of cibinetide in diabetic macular edema (DME). Phase 2 trial. Naïve patients with >400 µm central retinal thickness (CRT) DME in one/both eyes were recruited (May 2016-April 2017) at the Belfast Health and Social Care Trust. The study eye was that with best vision and lowest CRT. Patients self-administered cibinetide 4 mg/day subcutaneously for 12 weeks. Primary and secondary outcomes: mean change from baseline to week 12 in best corrected visual acuity (BCVA), CRT, central retinal sensitivity, tear production, patient-reported outcomes, adverse events and antibodies to cibinetide. Descriptive statistics were used; exploratory analyses focused on non-study eyes, diabetic control, serum cytokines and albuminuria. Nine patients were recruited; eight completed the study. There was no improvement in mean change baseline-week 12 in BCVA (-2.9 + 5.0), CRT (10 + 94.6 microns), central retinal sensitivity (-0.53 + 1.9 dB) or tear production (-0.13 + 7.7 mm), but there was an improvement in National Eye Institute Visual Function Questionnaire (NEI VFQ-25) composite scores (2.7 + 3.1). Some participants experienced improvements in CRT, tear production, diabetic control and albuminuria. No serious adverse events/reactions or anti-cibinetide antibodies were seen. The cibinetide 12-week course was safe. Improvements in NEI VFQ-25 scores, CRT, tear production, diabetic control and albuminuria, observed in some participants, warrant further investigation. EudraCT number: 2015-001940-12. ISRCTN16962255-registration date 25.06.15.
Study Information
pubmed
2020
2020-07-14T00:00:00.000Z
10.3390/jcm9072225
10
38