Health Condition 1: H351- Retinopathy of prematurity
Conditions
Interventions
Intervention1: RAZUMAB (Ranibizumab): Dose Formulation and strength, 0.2 mg solution for injection, Dosage Level: 0.2 mg administered as a single intravitreal injection once every 4 weeks (28 days), R
Sponsors
Intas Pharmaceuticals Limited
Eligibility
Inclusion criteria
Inclusion criteria: Participants are eligible to be included in the study only if all of the following criteria apply: (1) Parent(s) (preferably both if available or per local requirements) or their legally acceptable representative must sign an ICF indicating that they understand the purpose of, and procedures required for, the study and is willing to allow the child to participate in the study. Assent is also required of children capable of understanding the nature of the study described in Informed Consent Process in Appendix 10.1.3. (2) Male or female preterm infants with gestational age at birth less than or equal to 32 weeks OR birth weight less than or equal to 1500 g. (3) Weight at baseline (day of first injection) greater than or equal to 800 gm. (4) ROP classified according to the International Classification for ROP in at least one eye as: Zone I, stage 1+, 2+, 3 or 3+ disease, or Zone II, stage 3+ disease, or Aggressive posterior ROP. If both eyes are eligible, then both are included. If only one eye is eligible as per above criteria and the fellow eye has ROP but is not eligible, then fellow eye will receive the treatment as per investigator’s discretion. If one eye is eligible and the fellow eye later develops ROP during study, then the fellow eye will receive the treatment as per investigator’s discretion.
Exclusion criteria
Exclusion criteria: Any potential participant who meets any of the following criteria will be excluded from participating in the study: (1) Known allergies, hypersensitivity, or intolerance to any of the study interventions, or components/excipients thereof (refer to the locally approved package insert of Razumab[1]),, or drug or other allergy (either in the participant or mother) that, in the opinion of the investigator, contraindicates participation in the study. (2) Have ocular structural abnormalities that are assessed by the investigator to have a clinically significant impact on study assessments. (3) Have received any previous surgical or nonsurgical treatment for ROP (e.g., ablative laser therapy or cryotherapy, vitrectomy). (4) Have been previously exposed to any intravitreal or systemic anti-VEGF agent (either the patient or the mother during this childs pregnancy). (5) Have active ocular infection in the study eye within 5 days before or on the day of first IMP administration which is judged by the investigator to interfere with the study drug administration. (6) Have a history of hydrocephalus requiring treatment as judged by the investigator. (7) Have a history of any other neurological conditions that are assessed by the Investigator to have a significant risk of severe impact on visual function. (8) Have used (either the patient or the mother) other investigational drugs as part of another clinical study (other than vitamins and minerals) within 30 days or within 5 half-lives of the other investigational drug, whichever is longer. (9) Paediatric conditions rendering the infant ineligible for study intervention at baseline as evaluated by a NICU specialist and a study ophthalmologist. (10) Have any other medical conditions or clinically significant comorbidities or personal circumstances that are assessed by the Investigator to have a clinically relevant impact on study participation, any of the study procedures, or on efficacy assessments (e.g., poor life expectancy, pupil not able to be adequately dilated, unable to comply with the visit schedule). NOTE: Investigators should ensure that all study enrolment criteria have been met at screening. If a participants clinical status changes (including any available laboratory results or receipt of additional medical records) after screening but before the first dose of study intervention is given such that the participant no longer meets all eligibility criteria, then the participant should be reevaluated from participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ocular safety: Proportion of participants with ocular AEs and SAEs.Timepoint: From baseline to EOS visit. | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy: Number of ranibizumab administrations.Timepoint: From baseline to EOS visit;Efficacy: Proportion of participants requiring treatment in the study eye for ROP post first dose.Timepoint: From Day 15 to EOS visit;Efficacy: Proportion of participants with absence of active ROP.Timepoint: At EOS visit after starting study treatment;Efficacy: Proportion of participants with unfavourable structural outcomes.Timepoint: At EOS visit after starting study treatment;Systemic safety: Proportion of participants with systemic AEs and SAEs.Timepoint: From baseline to EOS visit | — |
Countries
India
Contacts
Public ContactPrashant Modi
Lambda Therapeutic Research Ltd
Outcome results
None listed