Autopsy report · NCT03810313

Assessing the Efficacy and Safety of Brolucizumab Versus Aflibercept in Patients With Visual Impairment Due to Macular Edema Secondary to Central Retinal Vein Occlusion

“Study was terminated by sponsor due to increased incidences of adverse events of special interest (intraocular inflammation including retinal vasculitis, and retinal vascular occlusion), in patients dosed every 4 weeks beyond 3 initial doses.”

The sponsor’s own words in the registry.

Life of this trial

• Registered 6 months before it started.
• Ran for about 2 years 1 month before it stopped.
• 493 participants enrolled.
• Results were posted on the registry 1 year after it ended.

Vital statistics

Status

Terminated

Phase

Phase 3

Sponsor

Novartis Pharmaceuticals

Sponsor type

Industry

Conditions

Central Retinal Vein Occlusion

Interventions

Brolucizumab 6 mg; Aflibercept 2 mg; Sham injection

Participants

493

Sites

120

Countries

Australia, Canada, China, Czechia, France, Germany, Greece, Hungary, Israel, Italy, Japan, Malaysia and more

Trials that died the same way

• Study to Evaluate the Safety of AT2220 (Duvoglustat) in Pompe Disease
  “Per protocol, 3 sequential dose cohorts were planned. Study discontinued by Sponsor based upon serious adverse events in first 2 of 3 participants in Cohort 1.” (66% match in meaning)
• A Study of THE-630 in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
  “The Sponsor terminated the study due to early dose-limiting toxicities.” (64% match in meaning)
• A Study of Obinutuzumab in Combination With CHOP Chemotherapy Versus Rituximab With CHOP in Participants With CD20-Positive Diffuse Large B-Cell Lymphoma (GOYA)
  “The study was closed by the Sponsor according to the protocol-specified minimum post-treatment follow-up period of 3 years.” (62% match in meaning)
• Safety and Efficacy Evaluation of Bosutinib Plus Atezolizumab in Newly Diagnosed Chronic Leukemia Adult Patients
  “The study has been prematurely terminated due to the onset of 2 dose limiting toxicities in 2 patients.” (62% match in meaning)
• Study to Determine the Safety and Efficacy of INCB018424 in Patients With Polycythemia Vera or Essential Thrombocythemia
  “Termination of the clinical trial by sponsor.” (61% match in meaning)

Look deeper

• The official registry record (the source of truth)
• Record history: every change the sponsor made
• Open it in the database

Everything here comes from the current ClinicalTrials.gov record. The timeline uses the record’s dates; dates marked planned are the sponsor’s plans. The cause of death is an automatic, unverified label. This is research information, not medical advice.