Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study to Evaluate THR-317 and Ranibizumab Combination Treatment for 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: NCT03499223
Recruitment Status : Active, not recruiting
First Posted : April 17, 2018
Last Update Posted : April 5, 2019
Sponsor:
Information provided by (Responsible Party):
Oxurion

Brief Summary:
This study is conducted to evaluate the safety of intravitreal THR-317 administered in combination with ranibizumab, and to assess the efficacy of the combination treatment in improving best-corrected visual acuity (BCVA) and reducing central subfield thickness (CST), in subjects with central-involved diabetic macular oedema (CI-DME).

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Diabetic Retinopathy Macular Edema Drug: Ranibizumab 0.5mg Drug: THR-317 8mg Drug: Sham injection Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Phase 2, Randomised, Single-masked, Active-controlled, Multicentre Study to Evaluate the Efficacy and Safety of Intravitreal THR-317 Administered in Combination With Ranibizumab, for the Treatment of Diabetic Macular Oedema (DME)
Actual Study Start Date : April 20, 2018
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema
Drug Information available for: Ranibizumab

Arm Intervention/treatment
Experimental: Ranibizumab + THR-317
Subjects will receive intravitreal ranibizumab in combination with THR-317
Drug: Ranibizumab 0.5mg
3 intravitreal injections of ranibizumab 0.5mg, approximately 1 month apart
Other Name: Lucentis®

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

Active Comparator: Sham + ranibizumab
Subjects will receive a sham injection in combination with intravitreal ranibizumab
Drug: Ranibizumab 0.5mg
3 intravitreal injections of ranibizumab 0.5mg, approximately 1 month apart
Other Name: Lucentis®

Drug: Sham injection
3 sham injections, approximately 1 month apart. No actual injections. No medication is used.




Primary Outcome Measures :
  1. Change from baseline in BCVA [ Time Frame: At Day 84 (Month 3) ]

Secondary Outcome Measures :
  1. Incidence of systemic and ocular adverse events including serious adverse events [ Time Frame: From Day 0 to Day 140 ]
  2. Change from baseline in BCVA, by study visit [ Time Frame: From Day 0 to Day 140 ]
  3. Change from baseline in CST, based on spectral domain optical coherence tomography (SD-OCT), as assessed by the central reading centre, by study visit [ Time Frame: From Screening to Day 140 ]
  4. Withdrawal from repeat study treatment and reason for withdrawal [ Time Frame: At Day 28 and at Day 56 ]
    Number of subjects meeting withdrawal criteria from repeat study treatment



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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 Mellitus
  • CI-DME with central subfield thickness of ≥ 320μm on Spectralis® SD-OCT or ≥ 305μm on non Spectralis SD-OCT, in the study eye
  • Anti-vascular endothelial growth factor (anti-VEGF) treatment naïve study eye, or poor or no response to prior treatment with ranibizumab in the study eye
  • Reduced vision primarily due to DME, with BCVA ≤ 72 and ≥ 23 ETDRS letter score (≤ 20/40 and ≥ 20/320 Snellen equivalent) in the study eye
  • Non-proliferative diabetic retinopathy of any stage in the study eye
  • Written informed consent obtained from the subject prior to screening procedures

Exclusion Criteria:

  • Concurrent disease in the study eye, other than CI-DME, that could compromise BCVA, require medical or surgical intervention during the study period or could confound interpretation of the results
  • Previous confounding treatments / procedures, or their planned / expected use during the study period for up to 30 days after the last administration of study treatment
  • Any active ocular / intraocular infection or inflammation in either eye
  • Aphakic study eye
  • Poorly controlled Diabetes Mellitus
  • Uncontrolled hypertension
  • 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

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): NCT03499223


  Show 37 Study Locations
Sponsors and Collaborators
Oxurion

Layout table for additonal information
Responsible Party: Oxurion
ClinicalTrials.gov Identifier: NCT03499223     History of Changes
Other Study ID Numbers: THR-317-002
2017-003897-15 ( EudraCT Number )
First Posted: April 17, 2018    Key Record Dates
Last Update Posted: April 5, 2019
Last Verified: April 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus
Edema
Macular Edema
Diabetic Retinopathy
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Ranibizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents