Phase 1 Study of THR-687, a Novel, Highly Potent Integrin Antagonist for the Treatment of Diabetic Macular Edema.

ABSTRACT:

Purpose

To evaluate the safety and preliminary efficacy of THR-687 in patients with center-involved diabetic macular edema (DME).

Design

Phase 1, open-label, multicenter, 3 + 3 dose-escalation study with 3-month follow-up.

Participants

Patients 18 years of age or older with visual impairment resulting from DME.

Methods

Single intravitreal injection of THR-687 (0.4 mg, 1.0 mg, or 2.5 mg).

Main outcome measures

The primary outcome measure was the incidence of dose-limiting toxicities (DLTs). The secondary outcome measure was the incidence of adverse events (AEs), including the occurrence of laboratory abnormalities. Exploratory outcome measures included changes from baseline in best-corrected visual acuity (BCVA) and central subfield thickness (CST), asses

SUBMITTER: Khanani AM 

PROVIDER: S-EPMC9562295 | biostudies-literature | 2021 Sep

REPOSITORIES: biostudies-literature