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

About this Study

This study will access the safety and effectiveness of aflibercept compared to laser in patients with Retinopathy of Prematurity (ROP).

Sponsor Protocol ID:VGFTe-ROP-1920
IRB Number:2020-0010
Actively Enrolling
Interventional
Phase 3
April 08, 2020
Eligibility Criteria
Both Male and Female
No
Yes
No

Inclusion Criteria1. Gestational age at birth ≤32 weeks or birth weight ≤1500 g 

2. Signed informed consent from parent(s)/legally authorized representative(s)

Exclusion Criteria1. Known or suspected chromosomal abnormality, genetic disorder, or syndrome

2. 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) 

3. 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  

4. Presence of active ocular infection within 5 days of the first treatment

5. Participation of the patient or the mother in other clinical trials requiring administration of investigational treatments (other than vitamins and minerals) at the time of screening, or within 30 days or 5 half-lives of administration of the previous study drug, whichever is longer

Categories Click category to view its trials.
Eyes/Vision
Pediatrics
Participating Locations
Children’s of Mississippi Hospital - Blair E. Batson Tower
Wiser Hospital for Women and Infants
Contact Information
Contact Name: Sandra Tyler
Phone Number: 601-815-8706
Email: sltyler@umc.edu
Principal Investigator:Shakti, Divya, M.D.
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