A Study to Evaluate THR-149 Treatment for Diabetic Macular Oedema
Public ClinicalTrials.gov record NCT04527107. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 2, Randomised, Multicentre Study to Assess the Dose Level of Multiple THR-149 Injections and to Evaluate the Efficacy and Safety of THR-149 Versus Aflibercept for the Treatment of Diabetic Macular Oedema (DME)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Part A of the study is conducted to select the THR-149 dose level. Part B of the study is conducted to assess the efficacy and safety of the selected dose level compared to aflibercept, up to Month 3. As from Month 3, in about half of the subjects, the effect of a single flip-over injection (aflibercept or THR-149) will be evaluated when administered 1 month after the 3 monthly injections of THR-149 or aflibercept. In the other subjects, the durability of 3 monthly injections of THR 149 or aflibercept will be evaluated.
Study identification
- NCT ID
- NCT04527107
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 135 participants
Conditions and interventions
Interventions
- THR-149 dose level 1 Drug
- THR-149 dose level 2 Drug
- THR-149 dose level 3 Drug
- THR-149 0.13mg Drug
- THR-149 0.13mg + aflibercept 2mg Drug
- aflibercept 2mg + THR-149 0.13mg Drug
- Aflibercept 2mg Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 31, 2020 (Actual)
- Primary completion
- Sep 28, 2023 (Actual)
- Completion
- Nov 22, 2023 (Actual)
- Last update posted
- Nov 27, 2023
2020 – 2023
United States locations
- U.S. sites
- 41
- U.S. states
- 18
- U.S. cities
- 35
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Retinal Research Institute, LLC | Phoenix | Arizona | 85053 | — |
| Retina Associates | Tucson | Arizona | 85704 | — |
| Retina-Vitreous Associates Medical Group | Beverly Hills | California | 90211 | — |
| Salehi Retina Institute Inc. | Huntington Beach | California | 92647 | — |
| Northern California Retina Vitreous Associates Medical Group, Inc. | Mountain View | California | 94040 | — |
| California Retina Consultants | Oxnard | California | 93036 | — |
| Retina Consultants San Diego | Poway | California | 92064 | — |
| Retinal Consultants Medical Group | Sacramento | California | 95825 | — |
| Retina Consultants of Southern Colorado, P.C. | Colorado Springs | Colorado | 80909 | — |
| Blue Ocean Clinical Research | Clearwater | Florida | 33761 | — |
| Fort Lauderdale Eye Institute | Plantation | Florida | 33324 | — |
| MedEye Associates | South Miami | Florida | 33143 | — |
| Center for Retina and Macular Disease | Winter Haven | Florida | 33880 | — |
| Southeast Retina Center | Augusta | Georgia | 30909 | — |
| Marietta Eye Clinic | Marietta | Georgia | 30060 | — |
| University Retina and Macula Associates, PC | Oak Forest | Illinois | 60452 | — |
| Cumberland Valley Retina Consultants | Hagerstown | Maryland | 21740 | — |
| Joslin Diabetes Center | Boston | Massachusetts | 02215 | — |
| Henry Ford Hospital | Detroit | Michigan | 48202 | — |
| Sierra Eye Associates | Reno | Nevada | 89502 | — |
| Retina-Vitreous Surgeons of Central New York, PC | Liverpool | New York | 13088 | — |
| Cincinnati Eye Institute | Cincinnati | Ohio | 45242 | — |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | — |
| Retina Associates of Cleveland, Inc | Cleveland | Ohio | 44122 | — |
| Sterling Vision, P.C. dba Oregon Retina | Eugene | Oregon | 97401 | — |
| Tenneesse Retina | Nashville | Tennessee | 37203 | — |
| Retina Research Institute of Texas | Abilene | Texas | 79606 | — |
| Austin Research Center for Retina | Austin | Texas | 78705 | — |
| Austin Retina Associates | Austin | Texas | 78705 | — |
| Retina Research Center, PLLC | Austin | Texas | 78705 | — |
| Texas Retina Associates | Dallas | Texas | 75231 | — |
| Houston Eye Associates | Houston | Texas | 77025 | — |
| Retina Consultants of Houston, PA | Houston | Texas | 77030 | — |
| Valley Retina Institute, PA | McAllen | Texas | 78503 | — |
| Medical Center Ophthalmology Associates | San Antonio | Texas | 78240 | — |
| Retina Associates of South Texas, P.A. | San Antonio | Texas | 78240 | — |
| Retina Consultants of Texas | San Antonio | Texas | 78240 | — |
| Retina Associates of Utah | Salt Lake City | Utah | 27560 | — |
| Piedmont Eye Center | Lynchburg | Virginia | 24502 | — |
| Wagner Macula & Retina Center | Norfolk | Virginia | 23502 | — |
| WVU Eye Institute | Morgantown | West Virginia | 26505 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 37 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04527107, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 27, 2023 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04527107 live on ClinicalTrials.gov.