A Study to Evaluate the Safety of THR-687 in Subjects With Diabetic Macular Edema (DME)

Phase 1

Completed

• Conditions: Diabetes Mellitus; Diabetic Macular Edema; Diabetic Retinopathy
• Interventions: Drug: THR-687 dose level 3; Drug: THR-687 dose level 2; Drug: THR-687 dose level 1

• Registration Number: NCT03666923
• Lead Sponsor: ThromboGenics

Brief Summary

This study is conducted to evaluate the safety of a single intravitreal injection of THR-687.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-09-07
• Study First Submitted QC: 2018-09-07
• Study First Posted: 2018-09-12
• Study Start: 2018-09-17
• Primary Completion: 2019-11-20
• Study Completion: 2019-11-20
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-20
• Last Update Posted: 2020-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• Male or female aged 18 years or older
• Type 1 or type 2 Diabetes Mellitus
• Central-involved DME with central subfield thickness of ≥ 320µm on Spectralis® spectral domain optical coherence tomography (SD-OCT) or ≥ 305µm on non-Spectralis SD-OCT, in the study eye
• Best-corrected visual acuity (BCVA) ≤ 62 and ≥ 23 ETDRS letter score in the study eye
• Written informed consent obtained from the subject prior to screening procedures

Exclusion Criteria

• Macular edema due to causes other than DME
• Concurrent disease in the study eye, other than central-involved DME, that could compromise BCVA, require medical or surgical intervention during the study period or could confound interpretation of the results
• Any condition that could confound the ability to detect a change in central subfield thickness in the study eye
• Previous confounding treatments / procedures, or expected to require confounding treatments / procedures at any time during the study period
• Presence of neovascularization at the disc (NVD) in the study eye
• Uncontrolled glaucoma in the study eye
• Any active ocular / intra-ocular infection or inflammation in either eye
• Poorly controlled Diabetes Mellitus
• Uncontrolled hypertension

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
THR-687 dose level 3	THR-687 dose level 3	Subjects in this arm will receive a single intravitreal injection of THR-687 dose level 3
THR-687 dose level 2	THR-687 dose level 2	Subjects in this arm will receive a single intravitreal injection of THR-687 dose level 2
THR-687 dose level 1	THR-687 dose level 1	Subjects in this arm will receive a single intravitreal injection of THR-687 dose level 1

Primary Outcome Measures

Name	Time	Method
Incidence of dose-limiting toxicities up to the Day 14 visit	From Day 0 up to Day 14

Secondary Outcome Measures

Name	Time	Method
Occurrence of laboratory abnormalities up to the end of the study	At Screening, Day 1, Day 7, Day 28 and Day 84
Incidence of systemic and ocular adverse events including serious adverse events up to the end of the study	From Day 0 up to Day 84

Trial Locations

Locations (7)

Center for Retina and Macular Disease; 🇺🇸 Winter Haven, Florida, United States

Midwest Eye Institute; 🇺🇸 Indianapolis, Indiana, United States

Palmetto Retinal Center; 🇺🇸 West Columbia, South Carolina, United States

Retina Research Institute of Texas; 🇺🇸 Abilene, Texas, United States

Valley Retina Institute, PA; 🇺🇸 McAllen, Texas, United States

Retina Consultants of Arizona; 🇺🇸 Phoenix, Arizona, United States

Sierra Eye Associates; 🇺🇸 Reno, Nevada, United States