Health Condition 1: H351- Retinopathy of prematurity
Conditions
Interventions
Intervention1: Ranibizumab (RaniEyes) 0.2 mg (0.02ml) intravitreal injection: Dose Formulation: Ranibizumab Solution for injection
Dose Strength(s):0.2 mg (0.02 ml)
Dosage Level(s) :Single injection
Sponsors
Lupin Limited
Veeda Clinica lResearch Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Unilateral or Bilateral ROP with zone I (stage 1+, 2+, 3 or 3+), zone II (stage 3+) or AP-ROP (aggressive posterior ROP) disease. 2. Infants- Weighing less than 2000 grams or Infants less than 34 weeks of gestation 3. At baseline the weight of the infants should be more than or equal to 800 gm. 4. Informed consent provided by the parents or legal guardians of the patient for participation in the study.
Exclusion criteria
Exclusion criteria: 1. ROP disease characteristic in either eye other than that listed above at the time of the first dosing of the study drug. 2. A history of hypersensitivity (either the patient or the mother) to any of the excipients or active pharmaceutical ingredients or to drugs of similar chemical classes or any known allergies due to any drug or other allergies. 3. Had received any previous surgical or nonsurgical treatment for ROP (e.g., ablative laser therapy or cryotherapy, vitrectomy) 4. Had been previously exposed to any intravitreal or systemic anti-VEGF agent (either the patient or the mother during pregnancy) 5. Had 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 was longer 6. Had ocular structural abnormalities that were assessed by the Investigator to have had a clinically significant impact on study assessments 7. Had active ocular infection within 5 days before or on the day of first dosing or active or suspected ocular or periocular infection or active intraocular inflammation 8. Had a history of hydrocephalus requiring treatment 9. Had a history of any other neurological conditions that are assessed by the Investigator to have a significant risk of severe impact on visual function 10. Had any other medical conditions or clinically significant comorbidities or personal circumstances that were 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the safety and tolerability of Injection Ranibizumab (of Sponsor Lupin Limited) as intravitreal injection in preterm infants with Retinopathy of Prematurity.Timepoint: safety assessment and Fundus examination will be performed on Visit 3, Day 2 (week 1) Visit 4, Day 8 (week 2) Visit 5, Day 29 (week 5) Visit 6, Day 57 (week 9) and Visit 7, Day 85, (week 13) | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the efficacy of Injection Ranibizumab (of Sponsor Lupin Limited) as intravitreal injection in preterm infants with Retinopathy of Prematurity.Timepoint: Efficacy will be assessed by Evaluation of regression of proliferative phase and/or complete peripheral retinal vascularization by the investigator at visit 3, visit 4, visit 5, visit 6 & visit 7. Number of infants without need for rescue treatment up to week 12 post first injection at visit 3, visit 4, visit 5, visit 6, & visit 7. The number of re-injections of study dose required in the patient s assessment of which will be done at visit 5, visit 6 & visit 7. | — |
Countries
India
Contacts
Public ContactMr Pramod V Kadam
Veeda Clinical research Limited
Outcome results
None listed