Effects of Copaxone in the Retinal Function in Diabetic Patients After Panphotocoagulation

What Was Tested

The trial (phase 4) is built around Glatiramer Acetate for diabetic retinopathy and glaucoma.

The purpose of this study is to evaluate the effects of Copaxone injections in retinal function and integrity in diabetic patients who underwent pan-retinal photocoagulation.

It had two arms (groups): A (active comparator) and B (placebo comparator).

Group which received Copaxone.

Group which received Mannitol.

The registry classes the interventions as drug.

More on the Plan

Purpose: to evaluate the neuroprotective effect of Copaxone (Glatiramer acetate) injections in the nerve fiber layer thickness and retinal function in diabetic patients who underwent panretinal photocoagulation (PRP).

Study Design: Double- Masked Randomized Clinical Trial.

The follow up period estimated is 12 months after the last PRP section.

Patients enrollment: Thirty patients with severe nonproliferative or early proliferative diabetic retinopathy and no previous laser treatment were enrolled.

Who Took Part

Enrollment: 30 actual participants took part.

It was open to people of any sex aged from 18 years up to 70 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Sex: Males or females; Females must be post-menopausal for 6 months and must have a negative pregnancy test (serum β-HCG) prior to study entry. Age: 18 to 70 years old. Type 1 or 2 diabetes, assigned for pan-retinal photocoagulation. Vision acuity 20/100 or better. SE of ±6,00 DE.

The full record lists 8 inclusion and 15 exclusion criteria; among the exclusions: eye related:; dense cataract or vitreous opacity; other retinal disease but diabetic retinopathy.

How the Study Was Run

It was run as a randomized, parallel-group and double-blind study.

Random assignment meant chance, not the researchers, decided who got Glatiramer Acetate and who got the comparison, which limits bias.

Groups ran in parallel: each of the diabetic retinopathy and glaucoma participants stayed in one arm throughout.

As a double-blind Glatiramer Acetate study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2006-07 with completion listed for 2008-07.

It ran at 1 site in Brazil.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Retinal function (time frame: one year).

It also tracked 1 secondary outcome, for example Nerve fiber layer thickness.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Glatiramer Acetate in 30 people with diabetic retinopathy and glaucoma.

Its size is small, so on its own it can only give an early look.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Glatiramer Acetate compound page, Diabetic retinopathy and glaucoma research.