Open-label, randomized, two*arm, controlled study to assess the efficacy, safety, and tolerability of intravitreal (IVT) aflibercept compared to laser photocoagulation in patients with retinopathy of prematurity (ROP)
- Conditions
- retinopathy of prematurityROP10047060
- Registration Number
- NL-OMON49302
- Lead Sponsor
- Bayer
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 2
1.Gestational age at birth * 32 weeks or birth weight * 1500 g, Type of
Participant and Disease Characteristics, 2.Subjects with treatment-naïve 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 AP-ROP, 3.Weight at baseline (day of treatment) *
800 g, 4.Male or female, 5.Signed informed consent from parent(s)/legally
authorized representative(s) as described in Section 10.1.3 of the clinical
trial protocol, which includes compliance with the requirements and
restrictions listed in the informed consent form (ICF) and in the clinical
trial protocol
Subjects are excluded from the study if any of the following *per subject*
criteria are met. A potential study eye is excluded from the study if any of
the *per eye* criteria are met:, Medical Conditions * per subject, 1.Known or
suspected chromosomal abnormality, genetic disorder or syndrome, 2.Previous
exposure to any IVT or systemic anti-VEGF agent, including maternal exposure
during pregnancy and/or during breastfeeding, 3.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), 4.Pediatric conditions rendering the infant ineligible
for study intervention at baseline or for repeated blood draws as evaluated by
a NICU specialist and a study ophthalmologist, 5.Presence of active ocular
infection within 5 days of the first treatment, Medical Conditions * per eye,
6.Advanced stages of ROP with partial or complete retinal detachment (ROP
Stages 4 and 5), 7.ROP involving only Zone III , 8.Ocular abnormalities that
may interfere with the administration of study intervention or assessment of
the study primary endpoint , Prior/Concomitant Therapy * per subject,
9.Postnatal treatment with oral or intravenous corticosteroids at an equivalent
dose of prednisone * 1 mg/kg/day for >2 weeks within 14 days of the first study
intervention, Prior/Concomitant Therapy * per eye, 10.Previous surgical or
nonsurgical treatment for ROP (IVT anti-VEGF injection, ablative laser therapy,
cryotherapy, and vitrectomy) , Prior/Concurrent Clinical Study Experience,
11.Participation of the subject 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>- Proportion of patients with absence of active ROP and unfavorable structural<br /><br>outcomes at 24 weeks after starting study treatment.</p><br>
- Secondary Outcome Measures
Name Time Method <p>- Number of requirement for intervention with a second treatment modality from<br /><br>baseline to week 24<br /><br>- Recurrence of ROP from baseline to week 24<br /><br>- To explore new ROP Activity Scale proposed by the International Neonatal<br /><br>Consortium from baseline to week 24<br /><br>- Number of aflibercept administrations from baseline to week 24.<br /><br>- Number of laser treatments from baseline to Week 24.<br /><br>- Proportion of participants with ocular TEAEs and SAEs from baseline to week<br /><br>24.<br /><br>- Proportion of participants with systemic TEAEs and SAEs from baseline to week<br /><br>24.<br /><br>- Systemic exposure to free aflibercept (at expected maximum plasma<br /><br>concentration and during elimination period from plasma) determined by sparse<br /><br>sampling from baseline to week 24.<br /><br>- Presence of anti-drug antibodies before and 12 weeks after aflibercept<br /><br>injection.</p><br>