A study to evaluate THR-317 the treatment of Macular Telangiectasia Type 1 (MacTel 1)

Phase 1

• Conditions: Macular Telangiectasia Type 1 (MacTel 1); MedDRA version: 20.1Level: PTClassification code 10038899Term: Retinal telangiectasiaSystem Organ Class: 10015919 - Eye disorders; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2017-004010-26-FR
• Lead Sponsor: ThromboGenics NV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-06-07
• Last Update Posted: 6 July 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

- Male or female aged 18 years or older
- Macular oedema caused by MacTel 1, with Central Subfield Thickness (CST) >300µm on spectral domain optical coherence tomography (SD-OCT)
- Written informed consent obtained from the subject prior to study procedures

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 5
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

- Type 1 or type 2 diabetes
- Medical history suggesting telangiectasia due to causes other than MacTel 1
- Concurrent disease in the study eye that could require medical or surgical intervention during the study period up to 30 days after the last study treatment, or could confound interpretation of the results
- Previous treatments / procedures as listed below, or their planned / expected use during the study period for up to 30 days after the last study treatment:
* Anti-vascular endothelial growth factor (anti-VEGF) treatment in the study eye (1 month)
* Intraocular surgery in the study eye (3 months)
* Laser photocoagulation in the study eye (3 months)
* Intraocular or periocular corticosteroids in the study eye (4 months)
* Ozurdex® (dexamethasone intravitreal implant) in the study eye (6 months)
* Other steroid implant in the study eye (any time)
- Uncontrolled glaucoma in the study eye
- Any active ocular / intraocular infection or inflammation in either eye
- Pregnant or lactating female
- Female of child-bearing potential not utilising an adequate form of contraception, or planning to become pregnant or to discontinue contraceptive precautions at any time during the entire study period
- Male of reproductive potential not utilising contraception

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Timepoint(s) of evaluation of this end point: Day 84 (Month 3);Main Objective: To evaluate the efficacy and safety of THR-317 for the treatment of MacTel 1;Secondary Objective: Not applicable;Primary end point(s): Change from baseline in CST

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - Change from baseline in CST, based on SD-OCT, by study visit<br>- Change from baseline area of cystoid spaces, based on SD-OCT, by study visit<br>- Change from baseline in BCVA, by study visit<br>- Incidence of systemic and ocular (serious) adverse events ([S]AEs), from first study treatment up to the end of the study;Timepoint(s) of evaluation of this end point: From first administration of study treatment up to end of study