Study to collect long-term data on patients treated in the VGFTe-ROP-1920 study that compared intravitreal aflibercept to laser photocoagulatio
Phase 1
- Conditions
- Retinopathy of prematurity (ROP)MedDRA version: 20.1Level: PTClassification code 10038933Term: Retinopathy of prematuritySystem Organ Class: 10015919 - Eye disordersTherapeutic area: Diseases [C] - Eye Diseases [C11]
- Registration Number
- EUCTR2020-005875-10-BG
- Lead Sponsor
- Regeneron Pharmaceuticals. Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 112
Inclusion Criteria
Key Inclusion Criteria:
1. Patient was treated in study VGFTe-ROP-1920
2. Age <13 months of chronological age
3. Signed informed consent from parent(s)/legal guardian(s), which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol
Are the trial subjects under 18? yes
Number of subjects for this age range: 112
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
1. Patient has a condition preventing participation in the study, or performance of study
procedures
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: • To evaluate binocular visual acuity at the end of this study in patients included from the VGFTe-ROP-1920 study, for treatment of ROP.<br>• To evaluate long-term safety outcomes in patients included from the VGFTe-ROP-1920 study, for treatment of ROP.;Secondary Objective: • To describe visual function in patients included from the VGFTe-ROP-1920 study, for treatment of ROP.<br>• To describe overall development in patients included from the VGFTe-ROP-1920 study, for treatment of ROP.;Primary end point(s): 1. Binocular best-corrected visual acuity (BCVA)<br>2. Proportion of Patients with Adverse Events<br>3. Proportion of Patients with Serious Adverse Events;Timepoint(s) of evaluation of this end point: 1-3. 5 years of chronological age.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1. Proportion of patients developing unfavorable ocular structural outcome<br>2. BCVA in each eye at 3 and 5 years of chronological age<br>3. Refractive spherical equivalent in each eye<br>4. Neurodevelopmental outcomes using Bayley Scales of Infant and Toddler Development (BSID-III)<br>5. Neurodevelopmental outcomes using echsler Preschool and Primary Scale of Intelligence, Fourth Edition (WPPSI-IV)<br>6. Neurodevelopmental outcomes using Vineland Adaptive Behavior Scales, Second Edition (VABS-II)<br>7. Proportion of patients with recurrence of ROP<br>8. Proportion of patients requiring treatment for ROP<br>For full information on secondary end points, see protocol.;Timepoint(s) of evaluation of this end point: 1-3, 7. 3 and 5 years of chronological age<br>4. 2 years of chronological age<br>5. 5 years of chronological age<br>6. 2 years of chronological age, 5 years of chronological age<br>8. Through 5 years of chronological age<br>