Study to Assess the Efficacy, Safety, and Tolerability of Intravitreal Aflibercept Compared to Laser Photocoagulation in Patients With Retinopathy of Prematurity
Purpose
The primary objective of the study is to assess the efficacy of aflibercept compared to laser in patients diagnosed with retinopathy of prematurity (ROP). The secondary objectives of the study are to assess the need for a second treatment modality, to assess the recurrence of ROP in the study and to assess the safety and tolerability of aflibercept.
Condition
- Retinopathy of Prematurity
Eligibility
- Eligible Ages
- All ages
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Gestational age at birth ≤ 32 weeks or birth weight ≤1500 g - Patients with treatment-naïve retinopathy of prematurity (ROP) classified according to the International Classification for ROP in at least one eye as: - Zone I Stage 1 plus, or 2 plus, or 3 non-plus or 3 plus, or - Zone II Stage 2 plus or 3 plus, or - Aggressive posterior retinopathy of prematurity (AP-ROP)
Exclusion Criteria
- Known or suspected chromosomal abnormality, genetic disorder, or syndrome - Previous exposure to any Intravitreal (IVT) or systemic anti-vascular endothelial growth factor (VEGF) agent, including maternal exposure during pregnancy and/or during breastfeeding - Clinically significant neurological disease (eg, intraventricular hemorrhage grade 3 or higher, periventricular leukomalacia, congenital brain lesions significantly impairing optic nerve function, severe hydrocephalus with significantly increased intracranial pressure) - Pediatric conditions rendering the infant ineligible for study intervention at baseline or for repeated blood draws as evaluated by a neonatal intensive care unit specialist and a study ophthalmologist - Presence of active ocular infection within 5 days of the first treatment - Advanced stages of ROP with partial or complete retinal detachment (ROP stage 4 and stage 5) - ROP involving only Zone III NOTE: Other protocol defined inclusion/exclusion criteria apply.
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
- Masking Description
- Open-Label
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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. |
|
More Details
- Status
- Completed
- Sponsor
- Regeneron Pharmaceuticals