Who is sponsoring NCT01591902?

NCT01591902 is sponsored by Theratechnologies.

What condition does NCT01591902 study?

NCT01591902 studies Diabetic Retinopathy, HIV.

What drugs are being tested in NCT01591902?

Interventions: Tesamorelin, Placebo-Control.

What is the status of NCT01591902?

NCT01591902 is currently TERMINATED.

Last reviewed 2018-09-10 · How we verify

A Prospective, Randomized, Placebo-controlled, Double-blind Clinical Trial to Evaluate Whether EGRIFTA® (Tesamorelin for Injection), 2 mg Once Daily SC, Increases the Risk of Development or Progression of Diabetic Retinopathy When Administered to HIV-infected Subjects With Abdominal Lipohypertrophy and Concomitant Diabetes

NCT01591902 Phase 4 TERMINATED

To show the non-inferiority of EGRIFTA® vs. placebo in the development or progression of Diabetic Retinopathy in HIV-infected subjects with concomitant abdominal lipohypertrophy and Type 2 diabetes mellitus (T2DM).

Details

Lead sponsor	Theratechnologies
Phase	Phase 4
Status	TERMINATED
Enrolment	129
Start date	2012-06
Completion	2018-08

Conditions

Diabetic Retinopathy
HIV

Interventions

Tesamorelin
Placebo-Control

Primary outcomes

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. — 3 years
Subjects will undergo an opthamologic examination including fundus photographs at 3 month intervals for duration of 36 months

Countries

United States