Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03481634 · ClinicalTrials.gov registry record · Phase 3
Study of Efficacy and Safety of Brolucizumab vs. Aflibercept in Patients With Visual Impairment Due to Diabetic Macular Edema
A Phase 3 study of Diabetic Macular Edema, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 566
- Enrollment target
- 20
- Study locations
NCT03481634: Completed Phase 3 study of Diabetic Macular Edema, sponsored by Novartis Pharmaceuticals.
NCT03481634 is a Phase 3 study of Diabetic Macular Edema that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 566 participants, below the 3,785-participant average among 63 other Diabetic Macular Edema trials with a reported enrollment target (85% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03481634, a Phase 3 study of Diabetic Macular Edema, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 566 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study was to evaluate the efficacy and safety of brolucizumab in treatment of patients with visual impairment due to diabetic macular edema (DME).
Primary Outcome
BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts. Visual Function of the study eye was assessed using the ETDRS protocol. Participants with a BCVA ETDRS letter score of 78 to 23 (approximate Snellen equivalent of 20/32 to 20/320) in the study eye were included. Min and max possible scores are 0-100 respectively. A higher score represents better visual functioning. This endpoint was analyzed via the pairwise ANOVA method where the 2 dose g
Conditions Studied
Interventions
- DRUG Aflibercept
- DRUG Brolucizumab
Study Locations (20)
California
- Novartis Investigative Site - Beverly Hills
- Novartis Investigative Site - La Jolla
- Novartis Investigative Site - Mountain View
- Novartis Investigative Site - Santa Barbara
Florida
- Novartis Investigative Site - Miami
- Novartis Investigative Site - Pensacola
- Novartis Investigative Site - Stuart
Illinois
- Novartis Investigative Site - Urbana
- Novartis Investigative Site - Wheaton
Indiana
- Novartis Investigative Site - Indianapolis
- Novartis Investigative Site - New Albany
Kansas
- Novartis Investigative Site - Leawood
- Novartis Investigative Site - Lenexa
Massachusetts
- Novartis Investigative Site - Springfield
- Novartis Investigative Site - Stoneham
Arizona
- Novartis Investigative Site - Phoenix
Colorado
- Novartis Investigative Site - Colorado Springs
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 566 participants |
| Start Date | 2018-07-23 |
| Est. Completion | 2021-10-18 |
| Phase | Phase 3 |
What the finished NCT03481634 record still lists
NCT03481634 is an interventional study that assigns participants to a tested intervention. The registered 566 participants enrollment target is mid-sized for trials with a published cap, below the 3,785-participant average among 63 other Diabetic Macular Edema trials with a reported enrollment target (85% lower).
The record links to 1 condition, with Diabetic Macular Edema appearing as the primary indexed condition, and to 2 interventions - of which Aflibercept is the first listed.
NCT03481634 names 20 study sites across 11 states, led by California, Florida, Illinois.
Frequently Asked Questions
What is clinical trial NCT03481634 about?
NCT03481634 is a clinical study titled "Study of Efficacy and Safety of Brolucizumab vs. Aflibercept in Patients With Visual Impairment Due to Diabetic Macular Edema". The purpose of this study was to evaluate the efficacy and safety of brolucizumab in treatment of patients with visual impairment due to diabetic macular edema (DME).
What is the current status of trial NCT03481634?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 566 participants. The study started on 2018-07-23. Estimated completion is 2021-10-18.
What conditions does trial NCT03481634 study?
This clinical trial studies the following conditions: Diabetic Macular Edema.
What interventions are being tested in trial NCT03481634?
The interventions under investigation include: Aflibercept (DRUG), Brolucizumab (DRUG).
Who is sponsoring clinical trial NCT03481634?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03481634 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Diabetic Macular Edema
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03481634's enrollment target sits among peer trials
566 7th of 63 higher than 57 of 63 other Diabetic Macular Edema trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetic Macular Edema trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
CAPRI: A Phase 3 Randomized, Double-Masked Study Comparing the Efficacy of EYP-1901 Against Aflibercept in DME
RECRUITING · Phase 3
-
A Study to Evaluate Efficacy, Safety & Pharmacokinetics of the Port Delivery System (PDS) With Ranibizumab in Participants With Diabetic Macular Edema (DME) Compared With Intravitreal Ranibizumab; A Substudy to Evaluate the Safety of Re-implanting the PDS With Ranibizumab in Participants With DME
RECRUITING · Phase 3
-
COMO: A Phase 3 Randomized, Double-Masked Study Comparing the Efficacy of EYP-1901 Against Aflibercept in DME
RECRUITING · Phase 3
-
A Phase 3b, Single-Arm Study of Aflibercept 8 mg Dosed Every 4 Weeks in Adult Participants With Neovascular Age-Related Macular Degeneration (nAMD) or Diabetic Macular Edema (DME)
ACTIVE NOT RECRUITING · Phase 3
-
A 3-month Study to Compare the Safety of ONS-5010 in Vials Versus Pre-filled Syringe in Subjects With Visual Impairment Due to Retinal Disorders
ACTIVE NOT RECRUITING · Phase 3
-
A Pivotal Safety and Efficacy Study of OCS-01 Eye Drops in Participants With Diabetic Macular Edema (DIAMOND 2)
ACTIVE NOT RECRUITING · Phase 3
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT05472441 · 568 participants · NA
Linking Education, Produce Provision, and Community Referrals to Improve Diabetes Care (LINK)
- NCT06146725 · 564 participants
The RESBIOP-study: Resection Versus Biopsy in High-grade Glioma Patients (ENCRAM 2202)
- NCT06188520 · 564 participants · Phase 1
A First-in-human Dose Escalation and Expansion Study to Evaluate the Safety, and Tolerability of AZD8421 Alone or in Combination in Participants With Selected Advanced or Metastatic Solid Tumors
- NCT06628453 · 564 participants · NA
CGM for Management of Type 2 Diabetes in Pregnancy
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI