A Study to Evaluate THR-317 Treatment for Macular Telangiectasia Type 1 (MacTel 1)

NCT03669393 | Completed Phase 2

• 2 other identifiers: THR-317-0032017-004010-26
• Study Type: interventional
• Target: 8
• Locations: 2 countries
• Sites: 3

Brief Summary

This study is conducted to evaluate the safety of THR-317 when administered intravitreally and to assess the compound's efficacy in reducing central subfield thickness (CST) and improving best-corrected visual acuity (BCVA) in subjects with macular telangiectasia Type 1 (MacTel 1).

Conditions

Retinal Telangiectasis; Idiopathic Juxtafoveal Retinal Telangiectasia

Outcome Measures

Primary Outcomes (1)

• Change from baseline in central subfield thickness (CST), based on spectral domain optical coherence tomography (SD-OCT)

  At Day 84 (Month 3)

Secondary Outcomes (4)

• Change from baseline in CST, based on SD-OCT, by study visit

  From baseline to Day 140

• Change from baseline in area of cystoid spaces, based on SD-OCT, by study visit

  From baseline to Day 140

• Change from baseline in best-corrected visual acuity (BCVA), by study visit

  From Day 0 to Day 140

• Incidence of systemic and ocular adverse events including serious adverse events

  From Day 0 to Day 140

Study Arms (1)

THR-317

EXPERIMENTAL

Drug: THR-317 8mg

Interventions

THR-317 8mg DRUG

3 intravitreal injections of THR-317 8mg, approximately 1 month apart

THR-317

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female aged 18 years or older
• Macular oedema caused by MacTel 1, with CST \>300µm on SD-OCT
• Written informed consent obtained from the subject prior to screening procedures

You may not qualify if:

• Type 1 or type 2 Diabetes Mellitus
• Concurrent disease in the study eye that could require medical or surgical intervention during the study period for up to 30 days after the last study treatment, or could confound interpretation of the results
• Previous confounding treatments / procedures, or their planned / expected use during the study period for up to 30 days after the last administration of study treatment
• Any active ocular / intraocular infection or inflammation in either eye
• Pregnant or lactating female, or female of child-bearing potential not utilising an adequate form of contraception, or male of reproductive potential not utilising contraception

Sponsors & Collaborators

• ThromboGenics: lead

Study Sites (3)

Hôpital Lariboisière

Paris, 75010, France

Location

Hôpital Cochin

Paris, 75181, France

Location

Hôpital Ophtalmique Jules-Gonin

Lausanne, 1000, Switzerland

Location

MeSH Terms

Conditions

Retinal Telangiectasis; Idiopathic Juxtafoveal Retinal Telangiectasia

Interventions

TB-403

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Telangiectasis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Clinical Department

  Oxurion NV.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2018
• First Posted: September 13, 2018
• Study Start: September 18, 2018
• Primary Completion: November 22, 2019
• Study Completion: November 22, 2019
• Last Updated: September 2, 2020

Record last verified: 2020-09

Locations

FR (2); CH (1)