Study to Assess the Efficacy, Safety, and Tolerability of Intravitreal Aflibercept Compared to Laser Photocoagulation in Patients With Retinopathy of Prematurity (BUTTERFLEYE)
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|ClinicalTrials.gov Identifier: NCT04101721|
Recruitment Status : Active, not recruiting
First Posted : September 24, 2019
Last Update Posted : December 21, 2021
|Condition or disease||Intervention/treatment||Phase|
|Retinopathy of Prematurity||Drug: aflibercept Procedure: laser photocoagulation||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||127 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomized, Controlled, Multi-Center Study to Assess the Efficacy, Safety, and Tolerability of Intravitreal Aflibercept Compared to Laser Photocoagulation in Patients With Retinopathy of Prematurity|
|Actual Study Start Date :||October 30, 2019|
|Estimated Primary Completion Date :||September 15, 2022|
|Estimated Study Completion Date :||September 15, 2022|
Experimental: Aflibercept Group
Patients will receive a single intravitreal (IVT) injection per eligible eye at baseline.
Experimental: Laser Group
Patients will undergo laser treatment in each eligible eye at baseline.
Procedure: laser photocoagulation
Transpupillary conventional laser will be administered according to standard local procedures.
- Proportion of patients with absence of active retinopathy of prematurity (ROP) and of unfavorable structural outcomes [ Time Frame: At Week 52 of chronological age ]For patients with both eyes enrolled in the study, both eyes must meet the endpoint.
- Proportion of patients requiring intervention with a second treatment modality [ Time Frame: Baseline to Week 52 of chronological age ]
- Proportion of patients with recurrence of ROP [ Time Frame: Through Week 52 of chronological age ]
- Proportion of patients with ocular treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) [ Time Frame: Baseline to Week 52 of chronological age ]
- Proportion of patients with systematic TEAEs and SAEs [ Time Frame: Baseline to Week 52 of chronological age ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04101721
|Study Director:||Clinical Trial Management||Regeneron Pharmaceuticals|