Cibinetide Improves Corneal Nerve Fiber Abundance in Patients With Sarcoidosis-Associated Small Nerve Fiber Loss and Neuropathic Pain.
A 64-subject randomized phase 2b trial improved a corneal nerve-fiber surrogate in one dose group, but the reported placebo-corrected pain difference was not statistically significant.
A 64-subject randomized phase 2b trial improved a corneal nerve-fiber surrogate in one dose group, but the reported placebo-corrected pain difference was not statistically significant.
Research summary
This 28-day trial randomized 64 subjects with sarcoidosis-associated nerve-fiber loss and neuropathic pain to three cibinetide groups or placebo. The primary endpoint was change in corneal nerve-fiber area. The middle dose group had a significant placebo-corrected increase (697 square micrometers; 95% CI 159–1236; P=0.012); the other groups did not have significant increases. Regenerating skin fibers also increased in the middle group. Pain improved in all groups; the reported placebo-corrected pain reduction in participants with moderate-to-severe pain had P=0.157.
Limitations and interpretation
A positive surrogate endpoint is not a confirmed pain-treatment effect. The pain comparison was not statistically significant, there was no simple monotonic dose-response pattern, and the study was short. See the 64-subject sarcoidosis registry summary NCT02039687 and its posted results for study context.
Source
Culver DA, Dahan A, Bajorunas D, et al. Cibinetide Improves Corneal Nerve Fiber Abundance in Patients With Sarcoidosis-Associated Small Nerve Fiber Loss and Neuropathic Pain. Investigative ophthalmology & visual science. 2017 May 1. DOI: 10.1167/iovs.16-21291. PMID: 28475703.
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
Research Goals
(2)For research use only. Not medical advice.