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.
Brief Title
Study to Assess the Efficacy, Safety, and Tolerability of Intravitreal Aflibercept Compared to Laser Photocoagulation in Patients With Retinopathy of Prematurity
Categories
Completion Date
Completion Date Type
Actual
Conditions
Retinopathy of Prematurity
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.
* 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.
Inclusion Criteria
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)
inclusion/
* 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)
inclusion/
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
NCT Id
NCT04101721
Org Class
Industry
Org Full Name
Regeneron Pharmaceuticals
Org Study Id
VGFTe-ROP-1920
Overall Status
Completed
Phases
Phase 3
Primary Completion Date
Primary Completion Date Type
Actual
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
Primary Outcomes
Outcome Description
Active ROP was ROP requiring treatment and unfavorable structural outcome was defined as retinal detachment, macular dragging, macular fold, or retrolental opacity. For participants with both eyes enrolled in the study, both eyes must have met the endpoint. Participants with only one study eye enrolled were responders if the respective eye responded.
Outcome Measure
Percentage of Participants With Absence of Active Retinopathy of Prematurity (ROP) and Unfavorable Structural Outcomes From Baseline to Week 52 of Chronological Age
Outcome Time Frame
Baseline to week 52 of chronological age
Secondary Ids
Secondary Id
2019-001764-29
Secondary Outcomes
Outcome Description
Second treatment modality includes any treatment in addition to that assigned to the participant at baseline. This includes per-protocol rescue treatment (laser for aflibercept group, aflibercept for laser group), anti-VEGF agents not part of study protocol (e.g., bevacizumab, ranibizumab, commercially-available aflibercept not provided as study medication), or any ocular surgery for the management of any retinal pathology secondary to ROP (e.g., victrectomy, scleral buckle for retinal detachments).
Outcome Time Frame
Baseline to to week 52 of chronological age
Outcome Measure
Percentage of Participants Requiring Intervention With a Second Treatment Modality From Baseline to Week 52 of Chronological Age
Outcome Description
Recurrence of disease is defined as the reappearance of the disease requiring further treatment (including retreatment or rescue), where both "presence of ROP" and "presence of active ROP requiring treatment" are marked as "Yes", after initial regression. Here, the initial regression is defined as, at a particular visit, absence of ROP or ROP treatment not required for active ROP, i.e., presence of ROP is marked as "No" or the presence of active ROP requiring treatment is marked as "No."
Outcome Time Frame
Baseline to week 52 of chronological age
Outcome Measure
Percentage of Participants With Recurrence of ROP Through Week 52 of Chronological Age
Outcome Time Frame
Baseline to Week 52 of chronological age
Outcome Measure
Percentage of Participants With Ocular Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
Outcome Time Frame
Baseline to Week 52 of chronological age
Outcome Measure
Percentage of Participants With Systematic (Non-ocular) TEAEs and TESAEs
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Child
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
0
Investigators
Investigator Type
Principal Investigator
Investigator Name
Umar Mian
Investigator Email
umian@montefiore.org
Investigator Phone
umian