Clinical trial NCT03071068: A Study to Evaluate the Safety and Efficacy of THR-317 for the Treatment of Diabetic Macular Oedema (DME)
Official 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetic Retinopathy
Macular Edema
Lead sponsor: ThromboGenics
Sponsor class: INDUSTRY
First posted: 2017-03-06
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).


Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: up to the 7-day follow-up visit after each injection
Secondary outcomes:
measure: Incidence of systemic and ocular (S)AEs up to the 30-day follow-up visit, after each injection and across injections per subject
timeFrame: up to the 30-day follow-up visit after each injection
measure: Incidence of systemic and ocular (S)AEs from first injection up to Day 90 and up to Day 150
timeFrame: From day 0 to day 150
measure: Proportion of subjects withdrawn from repeat injection and reason for withdrawal
timeFrame: At day 30 and at day 60
measure: Proportion of subjects with a loss of ≥ 15, ≥ 10 or ≥ 5 ETDRS letters in BCVA from baseline by study visit
timeFrame: Up to day 150
measure: 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
timeFrame: Up to 7-day follow-up visit after each injection
measure: Proportion of subjects with a ≥ 15 ETDRS letters gain in BCVA from baseline or ≥ 83 ETDRS letters, by study visit
timeFrame: Up to day 150
measure: Mean change from baseline in BCVA, by study visit
timeFrame: Up to day 150
measure: 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)
timeFrame: Up to day 150
Other outcomes:
Locations:
city: Brno
country: Czechia
city: Hradec Kralove
country: Czechia
city: Praha 10
country: Czechia
city: Praha 8
country: Czechia
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Debrecen
country: Hungary
city: Pecs
country: Hungary
city: Szeged
country: Hungary
city: Bratislava
country: Slovakia
city: Bratislava
country: Slovakia
city: Trenčín
country: Slovakia
city: Zilina
country: Slovakia
Study officials:
affiliation: ThromboGenics
name: Clinical Department
role: STUDY_DIRECTOR
References: