Clinical trial NCT04101721: Study to Assess the Efficacy, Safety, and Tolerability of Intravitreal Aflibercept Compared to Laser Photocoagulation in Patients With Retinopathy of Prematurity
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Retinopathy of Prematurity
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2019-09-24
Enrollment: 127
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants With Absence of Active Retinopathy of Prematurity (ROP) and Unfavorable Structural Outcomes From Baseline to Week 52 of Chronological Age
timeFrame: Baseline to week 52 of chronological age
Secondary outcomes:
measure: Percentage of Participants Requiring Intervention With a Second Treatment Modality From Baseline to Week 52 of Chronological Age
timeFrame: Baseline to to week 52 of chronological age
measure: Percentage of Participants With Recurrence of ROP Through Week 52 of Chronological Age
timeFrame: Baseline to week 52 of chronological age
measure: Percentage of Participants With Ocular Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
timeFrame: Baseline to Week 52 of chronological age
measure: Percentage of Participants With Systematic (Non-ocular) TEAEs and TESAEs
timeFrame: Baseline to Week 52 of chronological age
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Regeneron Study Site
state: Arizona
city: La Jolla
country: United States
facility: Regeneron Study Site
state: California
city: Loma Linda
country: United States
facility: Regeneron Study Site
state: California
city: Orange
country: United States
facility: Regeneron Study Site
state: California
city: Palo Alto
country: United States
facility: Regeneron Study Site
state: California
city: San Diego
country: United States
facility: Regeneron Study Site
state: California
city: San Francisco
country: United States
facility: Regeneron Study Site
state: California
city: Gainesville
country: United States
facility: Regeneron Study Site
state: Florida
city: Augusta
country: United States
facility: Regeneron Study Site
state: Georgia
city: Chicago
country: United States
facility: Regeneron Study Site
state: Illinois
city: Boston
country: United States
facility: Regeneron Study Site
state: Massachusetts
city: Ann Arbor
country: United States
facility: Regeneron Study Site
state: Michigan
city: Royal Oak
country: United States
facility: Regeneron Study Site
state: Michigan
city: Bronx
country: United States
facility: Regeneron Study Site
state: New York
city: Brooklyn
country: United States
facility: Regeneron Study Site
state: New York
city: Brooklyn
country: United States
facility: Regeneron Study Site
state: New York
city: Buffalo
country: United States
facility: Regeneron Study Site
state: New York
city: New York
country: United States
facility: Regeneron Study Site
state: New York
city: New York
country: United States
facility: Regeneron Study Site
state: New York
city: Valhalla
country: United States
facility: Regeneron Study Site
state: New York
city: Cleveland
country: United States
facility: Regeneron Study Site
state: Ohio
city: Oklahoma City
country: United States
facility: Regeneron Study Site
state: Oklahoma
city: Providence
country: United States
facility: Regeneron Study Site
state: Rhode Island
city: Austin
country: United States
facility: Regeneron Study Site
state: Texas
city: San Antonio
country: United States
facility: Regeneron Study Site
state: Texas
city: San Antonio
country: United States
facility: Regeneron Study Site
state: Texas
city: Morgantown
country: United States
facility: Regeneron Study Site
state: West Virginia
city: Sofia
country: Bulgaria
facility: Regeneron Study Site
city: Sofia
country: Bulgaria
facility: Regeneron Study Site
city: Varna
country: Bulgaria
facility: Regeneron Study Site
city: Medellin
country: Colombia
facility: Regeneron Study Site
state: Antioquia
city: Floridablanca
country: Colombia
facility: Regeneron Study Site
state: Santander
city: Ostrava-Poruba
country: Czechia
facility: Regeneron Study Site
city: Debrecen
country: Hungary
facility: Regeneron Study Site
city: Cheonan
country: Korea, Republic of
facility: Regeneron Study Site
city: Iași
country: Romania
facility: Regeneron Study Site
city: Saint-Petersburg
country: Russian Federation
facility: Regeneron Study Site
state: Sankt-Peterburg
city: Moscow
country: Russian Federation
facility: Regeneron Study Site
city: Moscow
country: Russian Federation
facility: Regeneron Study Site
city: Bratislava
country: Slovakia
facility: Regeneron Study Site
city: Kaohsiung
country: Taiwan
facility: Regeneron Study Site
city: Pathum Wan
country: Thailand
facility: Regeneron Study Site
state: Bangkok
city: Ratchathewi
country: Thailand
facility: Regeneron Study Site
state: Bangkok
city: Chiangmai
country: Thailand
facility: Regeneron Study Site
state: Chiang Mai
city: Hat Yai
country: Thailand
facility: Regeneron Study Site
state: Songkhla
city: Khon Kaen
country: Thailand
facility: Regeneron Study Site
city: Adana
country: Turkey
facility: Regeneron Study Site
city: Ankara
country: Turkey
facility: Regeneron Study Site
city: Ankara
country: Turkey
facility: Regeneron Study Site
city: Eskisehir
country: Turkey
facility: Regeneron Study Site
city: Ho Chi Minh
country: Vietnam
facility: Regeneron Study Site
city: Hue
country: Vietnam
facility: Regeneron Study Site
Study officials:
affiliation: Regeneron Pharmaceuticals
name: Clinical Trial Management
role: STUDY_DIRECTOR
References: