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

Diabetes Mellitus Clinical Trial

Official title:

A Phase 1, Open-label, Multicenter, Dose Escalation Study to Evaluate the Safety of a Single Intravitreal Injection of THR-687 for the Treatment of Diabetic Macular Edema (DME)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03666923
• Other study ID #: THR-687-001
• Status: Completed
• Phase: Phase 1
• Start date: September 17, 2018
• Est. completion date: November 20, 2019

Study information

• Verified date: January 2020
• Source: Oxurion
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: November 20, 2019
• Est. primary completion date: November 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetic Macular Edema
• Diabetic Retinopathy
• Edema
• Macular Edema

Intervention

Drug:
• THR-687 dose level 1
single intravitreal injection of THR-687 dose level 1
• THR-687 dose level 2
single intravitreal injection of THR-687 dose level 2
• THR-687 dose level 3
single intravitreal injection of THR-687 dose level 3

Locations

Country	Name	City	State
United States	Retina Research Institute of Texas	Abilene	Texas
United States	Midwest Eye Institute	Indianapolis	Indiana
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	Palmetto Retinal Center	West Columbia	South Carolina
United States	Center for Retina and Macular Disease	Winter Haven	Florida

Sponsors (1)

Lead Sponsor	Collaborator
ThromboGenics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of dose-limiting toxicities up to the Day 14 visit		From Day 0 up to Day 14
Secondary	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
Secondary	Occurrence of laboratory abnormalities up to the end of the study		At Screening, Day 1, Day 7, Day 28 and Day 84