Macular Telangiectasia Type 1 (MacTel 1) MedDRA version: 20.1 Level: PT Classification code 10038899 Term: Retinal telangiectasia System Organ Class: 10015919 - Eye disorders
Conditions
Interventions
Product Name: THR-317 8 mg
Product Code: THR-317
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Monoclonal antibody TG-403
Current Sponsor code: TB-403
Other descriptive name: TB-403
Sponsors
ThromboGenics NV
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Change from baseline in CST, based on SD-OCT, by study visit - Change from baseline area of cystoid spaces, based on SD-OCT, by study visit - Change from baseline in BCVA, by study visit - 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 | — |
Countries
France, Switzerland
Contacts
Public ContactGlobal Clinical Development
ThromboGenics NV
Outcome results
None listed