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Completed

NCT Number: NCT03071068

A Study to Evaluate the Safety and Efficacy of THR-317 for the Treatment of Diabetic Macular Oedema (DME)

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

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Key information

Conditions

Diabetic Retinopathy Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Endocrine System Diseases Eye Diseases Macular Degeneration Macular Edema Retinal Degeneration Retinal Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Brno, Czechia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female aged 18 years or older
  • Type 1 or type 2 diabetes
  • Centre-involved DME with CST ≥ 340µm on Spectralis SD-OCT or ≥ 320µm on non-Spectralis SD OCT, in the study eye
  • Reduced vision primarily due to DME, with BCVA between 72 and 23 ETDRS letters read at 4 meters (20/40 and 20/320 Snellen equivalent) in the study eye
  • Anti-vascular endothelial growth factor (anti-VEGF) treatment naïve study eye or poor response to prior anti-VEGF treatment in the study eye
  • Non-proliferative diabetic retinopathy, or stable proliferative diabetic retinopathy without neovacularisation at the disc
  • Written informed consent obtained from the subject prior to screening procedures

Exclusion criteria

  • Concurrent disease in the study eye, other than DME, that could compromise BCVA, require medical or surgical intervention during the study period or could confound interpretation of the results
  • Previous treatments / procedures in the study eyes as follows, or their planned use during the THR-317 treatment period for up to 30 days after the last injection: panretinal or focal / grid laser photocoagulation [3 months], anti-VEGF treatment [any time for anti-VEGF naïve subjects; 4 weeks for subjects with a poor response to anti-VEGF treatment], intra-ocular or peri-ocular corticosteroids [4 months], steroid implant [any time], intra-ocular surgery [3 months], vitrectomy [any time]
  • Any active ocular / intra-ocular infection or inflammation in either eye
  • Aphakic study eye
  • Untreated diabetes
  • Glycated haemoglobin A (HbA1c) > 12%
  • Uncontrolled hypertension in the opinion of the Investigator
  • 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 suggesting lens / zonular instability

Treatment and study plan

Anti-PlGF recombinant monoclonal antibody, 4mg dose

Drug

3 intravitreal injections of THR-317 4mg approximately 1 month apart

Anti-PlGF recombinant monoclonal antibody, 8mg dose

Drug

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

Primary outcomes

  1. Incidence of acute (up to the 7-day follow-up visit) ocular (serious) adverse events ([S]AEs) in the study eye, after each injection and across injections per subject

    Time frame: up to the 7-day follow-up visit after each injection

Secondary outcomes

  1. Incidence of systemic and ocular (S)AEs up to the 30-day follow-up visit, after each injection and across injections per subject

    Time frame: up to the 30-day follow-up visit after each injection

  2. Incidence of systemic and ocular (S)AEs from first injection up to Day 90 and up to Day 150

    Time frame: From day 0 to day 150

  3. Proportion of subjects withdrawn from repeat injection and reason for withdrawal

    Time frame: At day 30 and at day 60

  4. Proportion of subjects with a loss of ≥ 15, ≥ 10 or ≥ 5 ETDRS letters in BCVA from baseline by study visit

    Time frame: Up to day 150

  5. Proportion of subjects with an acute loss (up to the 7-day follow-up visit) of ≥ 15, ≥ 10 or ≥ 5 ETDRS letters in BCVA after each injection

    Time frame: Up to 7-day follow-up visit after each injection

  6. Proportion of subjects with a ≥ 15 ETDRS letters gain in BCVA from baseline or ≥ 83 ETDRS letters, by study visit

    Time frame: Up to day 150

  7. Mean change from baseline in BCVA, by study visit

    Time frame: Up to day 150

  8. Mean change from baseline in CST, by study visit, based on spectral domain optical coherence tomography (SD-OCT), as assessed by the central reading centre (CRC)

    Time frame: Up to day 150

Sponsors and collaborators

Lead sponsor

ThromboGenics

Industry

Registry information

Official study title

A Phase 2, Single-masked, Multicentre Study to Evaluate the Safety and Efficacy of 2 Dose Levels of THR-317 for the Treatment of Diabetic Macular Oedema (DME)

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Mar 6, 2017
Registry last updated
Apr 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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