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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03071068
Recruitment Status : Completed
First Posted : March 6, 2017
Last Update Posted : April 17, 2018
Sponsor:
Information provided by (Responsible Party):
ThromboGenics

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).

Condition or disease Intervention/treatment Phase
Diabetic Retinopathy Macular Edema Drug: Anti-PlGF recombinant monoclonal antibody, 4mg dose Drug: Anti-PlGF recombinant monoclonal antibody, 8mg dose Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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)
Actual Study Start Date : December 22, 2016
Actual Primary Completion Date : April 2018
Actual Study Completion Date : April 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Arm Intervention/treatment
Experimental: THR-317 4mg
anti-PlGF recombinant monoclonal antibody, 4mg dose
Drug: Anti-PlGF recombinant monoclonal antibody, 4mg dose
3 intravitreal injections of THR-317 4mg approximately 1 month apart

Experimental: THR-317 8mg
anti-PlGF recombinant monoclonal antibody, 8mg dose
Drug: Anti-PlGF recombinant monoclonal antibody, 8mg dose
3 intravitreal injections of THR-317 8mg approximately 1 month apart




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03071068


Locations
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Czechia
Brno, Czechia, 625 00
Hradec Kralove, Czechia, 500 05
Praha 10, Czechia, 100 34
Praha 8, Czechia, 180 00
Hungary
Budapest, Hungary, 1083
Budapest, Hungary, 1133
Debrecen, Hungary, 4032
Pecs, Hungary, 7621
Szeged, Hungary, 6720
Slovakia
Bratislava, Slovakia, 826 06
Bratislava, Slovakia, 851 07
Trenčín, Slovakia, 911 71
Zilina, Slovakia, 012 07
Sponsors and Collaborators
ThromboGenics
Investigators
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Study Director: Clinical Department ThromboGenics
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Responsible Party: ThromboGenics
ClinicalTrials.gov Identifier: NCT03071068    
Other Study ID Numbers: THR-317-001
2016-002100-25 ( EudraCT Number )
First Posted: March 6, 2017    Key Record Dates
Last Update Posted: April 17, 2018
Last Verified: April 2018
Additional relevant MeSH terms:
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Macular Edema
Diabetic Retinopathy
Edema
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Antineoplastic Agents, Immunological
Antibodies
Immunoglobulins
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents