Cibinetide Improves Corneal Nerve Fiber Abundance in Patients With Sarcoidosis-Associated Small Nerve Fiber Loss and Neuropathic Pain

What Was Tested

The paper reports a study of ARA-290, published as a randomized controlled trial.

Sarcoidosis frequently is complicated by small nerve fiber loss (SNFL), which can be quantified using corneal confocal microscopy (CCM).

This phase 2b, 28-day, randomized trial of 64 subjects with sarcoid-associated SNFL and neuropathic pain assessed the effect of cibinetide on corneal nerve fiber area (CNFA) and regenerating intraepidermal fibers (GAP-43+) as surrogate endpoints for disease modification, pain severity, and functional capacity (6-minute walk test [6MWT]).

Who Took Part

The study group was 64 subjects.

PubMed indexes the participants as teenagers, young adults, adults, middle-aged adults and older adults, both men and women.

How the Study Was Run

The design is described as randomized, double-blind and placebo-controlled.

Because people in this ARA-290 study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Neither the subjects nor the staff measuring them knew who was on ARA-290, so expectations could not easily colour the readings.

Some subjects received a placebo instead of ARA-290, giving a reference point.

The primary study endpoint was a change in CNFA at 28 days.

What Was Measured

The subject headings attached to it are Cornea, Microscopy, Confocal, Nerve Fibers, Neuralgia, Oligopeptides and Sarcoidosis.

What This Means in Plain Language

The paper is a randomized, double-blind and placebo-controlled study of ARA-290 in 64 subjects.

Its findings take up roughly 6 sentences of the abstract and are left out here on purpose; the source paper is the place to read them.

The publication is from 2017 (Investigative ophthalmology & visual science), a journal based in United States.

More context: the ARA-290 compound page, all human trials.