Trial to Assess the Efficacy of Neuroprotective Drugs Administered Topically to Prevent or Arrest Diabetic Retinopathy

What Was Tested

The trial (phase 2, phase 3) is built around Somatostatin for diabetic retinopathy and glaucoma.

It had three arms (groups): COLIRIOBCN070660 (experimental), Placebo (placebo comparator) and Brimonidine (experimental).

Placebo Eye drops, solution. One drop/eye administered twice a day.

The registry classes the interventions as drug.

Who Took Part

450 actual participants took part.

It was open to people of any sex aged from 45 years up to 75 years.

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

Examples of who could join: Patients with type 2 diabetes mellitus. Diabetes duration ≥ 5 years. Aged between 45-75 years-old.

The full record lists 5 inclusion and 11 exclusion criteria; among the exclusions: previous laser photocoagulation; other diseases which may induce retinal degeneration (e.g. glaucoma); subject with a refractive error ≥ ± 5 diopter.

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-blind.

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

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

Blinding on both sides kept the diabetic retinopathy and glaucoma participants and researchers unaware of who received Somatostatin.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2013-02 with completion listed for 2015-11.

It ran at 11 sites in United Kingdom (4), Italy (2), Denmark (1), France (1), Germany (1) and Portugal (1).

Its stated primary purpose is prevention.

What Was Measured

Researchers chose this as the main measure: Changes in the Implicit Time assessed by mfERG (IT-mfERG) at month 6, 12, 18 and 24 (time frame: month 24).

It also tracked 27 secondary outcomes, for example Retinal Nerve Fiber Layer (RNFL) assessed by Spectral Domain Optical Coherence Tomography (SD-OCT) at month 0, Retinal Nerve Fiber Layer (RNFL) assessed by SD-OCT at month 6, Retinal Nerve Fiber Layer (RNFL) assessed by SD-OCT at month 12, Retinal Nerve Fiber Layer (RNFL) assessed by SD-OCT at month 18, Retinal Nerve Fiber Layer (RNFL) assessed by SD-OCT at month 24 and Ganglion Cell Layer (GCL) assessed by SD-OCT at month 0.

What This Means in Plain Language

Put simply, this is a phase 2, phase 3, randomized trial of Somatostatin in 450 people with diabetic retinopathy and glaucoma.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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