Efficacy and Safety of Low-dose Conbercept for Retinopathy of Prematurity Therapy: A Multicenter, Prospective, Randomized, Double-blind, Non-inferiority Clinical Trial
Status: Recruiting
Location: See all (3) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
Evaluating the Optimal Effective Dose and Safety of Conbercept in Treating Retinopathy of Prematurity (ROP)
Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:
• Preterm infants with less than or equal to 2000 grams of birth weight or less than or equal to 32 weeks of gestational age
• Bilateral type 1 ROP with one of the following retinal findings in each eye
• Zone I, stage 1+, 2+, 3+/- disease, or
• Zone II, stage 2+, 3+, disease, or
• A-ROP
Locations
Other Locations
China
Department of Ophthalmology, the Second Affiliated Hospital of Xi'an Medical University
RECRUITING
Xi'an
Department of Ophthalmology, Xijing Hospital, Air Force Military Medical University
RECRUITING
Xi'an
Department of Ophthalmology, Xianyang Rainbow Hospital
RECRUITING
Xianyang
Contact Information
Primary
Wang
wangys003@126.com
02984771794
Time Frame
Start Date: 2024-11-29
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 146
Treatments
Active_comparator: Conbercept 0.25 mg/0.025mL
intravitreal injection in both eyes on Day 0, with up to 1 re-treatment allowed for each eye if required
Experimental: Conbercept 0.15 mg/0.015mL
intravitreal injection in both eyes on Day 0, with up to 1 re-treatment allowed for each eye if required
Related Therapeutic Areas
Sponsors
Leads: Wang Yusheng