Trial Search Results

Study to Assess the Efficacy, Safety, and Tolerability of Intravitreal Aflibercept Compared to Laser Photocoagulation in Patients With Retinopathy of Prematurity

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.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Regeneron Pharmaceuticals

Stanford Investigator(s):

Intervention(s):

  • Drug: aflibercept
  • Procedure: laser photocoagulation

Phase:

Phase 3

Eligibility


Key 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)

Key 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.

Ages Eligible for Study

N/A - N/A

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Recruiting