A Dose Ranging Study of OPT-302 With Aflibercept for Persistent Diabetic Macular Edema
Public ClinicalTrials.gov record NCT03397264. 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
Phase 1b/2a Study of OPT-302 in Combination With Aflibercept for Persistent Central-involved Diabetic Macular Edema
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
A two part, multi-center study consisting of a Phase 1b open label, sequential dose escalation followed by a Phase 2a randomized, double-masked, dose expansion evaluating OPT-302 in combination with aflibercept in participants with persistent central-involved Diabetic Macular Edema.
Study identification
- NCT ID
- NCT03397264
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 153 participants
Conditions and interventions
Conditions
Interventions
- Aflibercept Biological
- OPT-302 Biological
- Sham intravitreal injection Other
Biological · Other
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
- Jan 16, 2018 (Actual)
- Primary completion
- Mar 26, 2020 (Actual)
- Completion
- Jun 11, 2020 (Actual)
- Last update posted
- Apr 22, 2025
2018 – 2020
United States locations
- U.S. sites
- 34
- U.S. states
- 17
- U.S. cities
- 34
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Opthea Investigational Site | Phoenix | Arizona | 85014 | — |
| Opthea Investigational Site | Bakersfield | California | 93309 | — |
| Opthea Investigational Site | Beverly Hills | California | 90211 | — |
| Opthea Investigational Site | Redlands | California | 92374 | — |
| Opthea Investigational Site | Sacramento | California | 95819 | — |
| Opthea Investigational Site | Santa Ana | California | 92705 | — |
| Opthea Investigational Site | Colorado Springs | Colorado | 30909 | — |
| Opthea Investigational Site | Boynton Beach | Florida | 33426 | — |
| Opthea Investigational Site | Fort Myers | Florida | 33912 | — |
| Opthea Investigational Site | Melbourne | Florida | 32901 | — |
| Opthea Investigational Site | Pensacola | Florida | 32503 | — |
| Opthea Investigational Site | St. Petersburg | Florida | 33711 | — |
| Opthea Investigational Site | Augusta | Georgia | 30909 | — |
| Opthea Investigational Site | Indianapolis | Indiana | 46290 | — |
| Opthea Investigational Site | Des Moines | Iowa | 50266 | — |
| Opthea Investigational Site | Wichita | Kansas | 67214 | — |
| Opthea Investigational Site | Hagerstown | Maryland | 21740 | — |
| Opthea Investigational Site | Las Vegas | Nevada | 89144 | — |
| Opthea Investigational Site | Reno | Nevada | 89502 | — |
| Opthea Investigational Site | Asheville | North Carolina | 28803 | — |
| Opthea Investigational Site | Charlotte | North Carolina | 28210 | — |
| Opthea Investigational Site | Youngstown | Ohio | 92705 | — |
| Opthea Investigational Site | Portland | Oregon | 97213 | — |
| Opthea Investigational Site | Charleston | South Carolina | 29414 | — |
| Opthea Investigational Site | West Columbia | South Carolina | 29169 | — |
| Opthea Investigational Site | Rapid City | South Dakota | 57701 | — |
| Opthea Investigational Site | Germantown | Tennessee | 38138 | — |
| Opthea Investigational Site | Abilene | Texas | 79606 | — |
| Opthea Investigational Site | Arlington | Texas | 76012 | — |
| Opthea Investigational Site | Austin | Texas | 78705 | — |
| Opthea Investigational Site | Houston | Texas | 77030 | — |
| Opthea Investigational Site | McAllen | Texas | 78503 | — |
| Opthea Investigational Site | San Antonio | Texas | 78240 | — |
| Opthea Investigational Site | Willow Park | Texas | 76087 | — |
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 19 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03397264, 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 Apr 22, 2025 · Synced Oct 26, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03397264 live on ClinicalTrials.gov.