Autopsy report · NCT03203447

Suprachoroidal Injection of Triamcinolone Acetonide With IVT Anti-VEGF in Subjects With Macular Edema Following RVO

“The early termination is due to the results obtained from the sister study, SAPPHIRE (CLS1003-301), which did not meet the 8-week primary efficacy endpoint.”

The sponsor’s own words in the registry.

Life of this trial

• Registered 8 months before it started.
• Ran for about 9 months before it stopped.
• 325 participants enrolled.
• Results were posted on the registry 2 years 4 months after it ended.

Vital statistics

Status

Terminated

Phase

Phase 3

Sponsor

Clearside Biomedical, Inc.

Sponsor type

Industry

Conditions

Macular Edema; Retinal Vein Occlusion

Interventions

suprachoroidal CLS-TA; suprachoroidal sham; Lucentis or Avastin

Participants

325

Sites

92

Countries

Australia, Hungary, India, New Zealand, United States

Trials that died the same way

• PFC Sigma Fixed and Mobile Knee Study
  “The study was terminated at the point the primary endpoint and early milestones were reached and because long term outcomes were available from other sources” (66% match in meaning)
• Ixazomib -Daratumumab Without Dexamethasone (IDara) in Elderly Relapse Refractory Multiple Myeloma
  “Early termination (regarding the follow-up of the patients). The required sample size was reached, and the primary endpoint was met.” (63% match in meaning)
• Telaprevir, Peg-IFN-alfa-2a, and RBV in Treatment-Experienced Black/African American and Non-Black/African American Subjects With Genotype 1 Chronic Hepatitis C
  “It was decided by Sponsor on 13 January 2014 to terminate study early at primary efficacy endpoint as part of a decision to modify drug development plan.” (62% match in meaning)
• A Long-Term Safety And Tolerability Study Of Bapineuzumab In Alzheimer Disease Patients
  “The study was terminated on August 6, 2012, because 2 large Phase 3 studies showed no clinical benefit. This decision was not based on any new safety concerns.” (61% match in meaning)
• A Study Of Safety, Tolerability And Effectiveness Of Recifercept In Children With Achondroplasia
  “The study was terminated due to lack of efficacy at any of the tested doses on 18th November 2022. The decision to terminate the study is not related to a safety concern.” (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.