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NCT03531294
Intravitreal Aflibercept as Indicated by Real-Time Objective Imaging to Achieve Diabetic Retinopathy Improvement
Phase 2 trial testing Aflibercept Injection in Diabetic Retinopathy in 40 participants. Completed in 9 April 2021.
9 April 2021
Quick facts
| Lead sponsor | Greater Houston Retina Research |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 40 |
| Start date | 23 May 2018 |
| Primary completion | 9 April 2021 |
| Estimated completion | 9 April 2021 |
| Sites | 2 locations across United States |
Drugs / interventions tested
- Aflibercept Injection — full drug profile →
Conditions studied
- Diabetic Retinopathy — all drugs for Diabetic Retinopathy →
Sponsor
Greater Houston Retina Research — full company profile →
Who can join
18 and older, any sex, with Diabetic Retinopathy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The PRIME trial will assess the safety of 2 mg intravitreal aflibercept injections (IAI) to achieve and maintain DRSS improvements (2 or more steps) in patients with a baseline DRSS level of 47A to 71A inclusive through 104 weeks as determined by reading center determined DRSS gradings on OPTOS fundus photos and leakage index on OPTOS WF-FA.
Publications & conference data
6 peer-reviewed publications reference this trial (live from Europe PMC):
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Retinal non-perfusion in diabetic retinopathy.
Wykoff CC, Yu HJ, Avery RL, Ehlers JP, et al · · 2022 · cited 37× · PMID 35017700 · DOI 10.1038/s41433-021-01649-0 -
Weakly-Supervised Vessel Detection in Ultra-Widefield Fundus Photography via Iterative Multi-Modal Registration and Learning.
Ding L, Kuriyan AE, Ramchandran RS, Wykoff CC, et al · · 2021 · cited 28× · PMID 32991281 · DOI 10.1109/tmi.2020.3027665 -
Deep learning-enabled ultra-widefield retinal vessel segmentation with an automated quality-optimized angiographic phase selection tool.
Sevgi DD, Srivastava SK, Wykoff C, Scott AW, et al · · 2022 · cited 5× · PMID 34373610 · DOI 10.1038/s41433-021-01661-4 -
Real-Time Diabetic Retinopathy Severity Score Level versus Ultra-Widefield Leakage Index-Guided Management of Diabetic Retinopathy: Two-Year Outcomes from the Randomized PRIME Trial.
Yu HJ, Ehlers JP, Sevgi DD, O'Connell M, et al · · 2021 · cited 3× · PMID 34575662 · DOI 10.3390/jpm11090885 -
Longitudinal Quantitative Ultrawidefield Angiographic Features in Diabetic Retinopathy Treated with Aflibercept from the Intravitreal Aflibercept as Indicated by Real-Time Objective Imaging to Achieve Diabetic Retinopathy Improvement Trial.
Kalra G, Wykoff C, Martin A, Srivastava SK, et al · · 2024 · cited 2× · PMID 37696393 · DOI 10.1016/j.oret.2023.09.004 -
Dynamic versus static ultra-widefield fluorescein angiography in eyes with diabetic retinopathy: a pilot prospective cross-sectional study.
Shen HQ, Wang J, Niu T, Chen JL, et al · · 2021 · cited 1× · PMID 33747818 · DOI 10.18240/ijo.2021.03.13
Verify or expand the search:
- PubMed search for NCT03531294
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Aflibercept Injection
Trials testing the same drug.
- NCT06116890 — Study to Assess the Efficacy & Safety of KHK4951 in Patients With Neovascular Age-Related Macular Degeneration · Phase 2 · active not recruiting
- NCT06116916 — Study to Assess the Efficacy & Safety of KHK4951 in Patients With Diabetic Macular Edema · Phase 2 · active not recruiting
- NCT04708145 — Long-Term Efficacy and Safety of Intravitreal Aflibercept Injections for the Treatment of Diabetic Retinopathy for Subje · Phase 4 · completed
- NCT04655482 — Treat-and-extend Using Aflibercept for Type 3 Neovascularization · Phase 4 · unknown
- NCT04702048 — Evaluation of the Retina in Patients With Non-proliferative Diabetic Retinopathy After Aflibercept Injection in the Eye · Phase 4 · withdrawn
Other recruiting trials for Diabetic Retinopathy
Currently open trials in the same condition.
- NCT07255326 — Effect of Omega-3 Fatty Acids on Eye Blood Vessels in Type 1 Diabetes · NA · recruiting
- NCT06782997 — Performance of the Electroretinogram, Performed and Interpreted by an Advanced Practice Nurse, in the Screening for Diab · recruiting
- NCT07002372 — Effect of Video Viewing on Intravitreal Injection Experience · NA · recruiting
- NCT06713720 — Remote Ischemic Conditioning for Non-Proliferative Diabetic Retinopathy · NA · recruiting
- NCT06892353 — AI-Powered DIY Screening System for Diabetic Retinopathy · NA · recruiting
Other Greater Houston Retina Research trials
Trials by the same sponsor.
- NCT05681884 — Safety and Efficacy of Faricimab in Patients With NPDR · Phase 2 · completed
- NCT05333055 — Aqueous Biomarker Levels in Diabetic Retinopathy and Diabetic Macular Edema · terminated
- NCT04708145 — Long-Term Efficacy and Safety of Intravitreal Aflibercept Injections for the Treatment of Diabetic Retinopathy for Subje · Phase 4 · completed
- NCT02299336 — Long-Term Efficacy & Safety of Aflibercept IVT for the Treatment of DME in Subjects Who Completed the VISTA-DME Trial · Phase 4 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03531294 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Greater Houston Retina Research
- Last refreshed: 21 May 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03531294.
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