Diabetic Retinopathy in HIV Subjects Treated With EGRIFTA®

What Was Tested

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

It had two arms (groups): EGRIFTA Treatment Grop (experimental) and Placebo (placebo comparator).

Sterile, lyophilized, nonpyrogenic powder containing tesamorelin acetate with mannitol as excipient.

Placebo-controlled.

The registry classes the interventions as drug.

Who Took Part

129 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Subject has given written informed consent and is willing to comply with the requirements of the protocol;. Subject is an adult man or woman (≥ 18 years old);. Subject has laboratory confirmed HIV infection;. Subject is receiving ART that has been stable for at least 8 weeks prior to screening;. Subject has physical evidence of abdominal lipohypertrophy, as determined by the examining study physician;.

The full record lists 16 inclusion and 22 exclusion criteria; among the exclusions: subject has type 1 dm;; subject has body mass index (bmi) \< 18.5 kg.m2;; subject has or has had an opportunistic infection or acquired immune deficiency syndrome (aids)-defining illness within 3 months of screening;.

How the Study Was Run

Design: randomized, parallel-group and double-blind.

Because people in this Tesamorelin 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 Tesamorelin.

Those kept unaware of assignments: investigator and outcomes assessor.

It started in 2012-06 with completion listed for 2018-05.

It ran at 24 sites in United States (24).

Its stated primary purpose is prevention.

What Was Measured

The main thing measured (primary outcome): Difference in percentages of subjects with a 3-step or greater progression (from both eyes) on the Early Treatment Diabetic Retinopathy Study (ETDRS) PERSON scale (time frame: 3 years).

It also tracked 1 secondary outcome, for example Change from baseline in HbA1c by intensification of concomitant diabetic treatment.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Tesamorelin in 129 people with diabetic retinopathy and glaucoma.

It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.

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