Efficacy and Safety of Low-dose Conbercept for Retinopathy of Prematurity Therapy

NCT06717412 | Recruiting

• 1 other identifier: KY20242291
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 3

Brief Summary

Evaluating the Optimal Effective Dose and Safety of Conbercept in Treating Retinopathy of Prematurity (ROP)

Conditions

Retinopathy of Prematurity (ROP)

Outcome Measures

Primary Outcomes (1)

• Percentage of participants with absence of active ROP and absence of unfavorable structural outcomes in both eyes during the observational period after starting study treatment

  To achieve this outcome, participants cannot fulfill any of the following criteria: 1. Require intervention for ROP in either eye at or before the week 24 assessment visit with a treatment modality other than Conbercept 2. Have active ROP in either eye at the week 24 assessment visit 3. Have unfavorable structural outcomes (e.g., retinal detachment, retinal traction, macular abnormalities) in either eye at or before week 24 assessment visit

  Week 24

Secondary Outcomes (5)

• Percentage of participants with effective single intravitreal injection treatment

  Week 24

• Percentage of participants having reactivation at or before week 24

  Week 24

• Percentage of participants with complete vascularization of the peripheral retina at or before week 24

  Week 24

• Percentage of participants requiring repeated intervention at or before week 24

  Week 24

• Percentage of participants requiring interventions with a second modality for ROP at or before week 24

  Week 24

Other Outcomes (1)

• VEGF levels in the systemic circulation

  Before the first treatment (Day 0), Day 1, Week 1 and Week 24

Study Arms (2)

Conbercept 0.25 mg/0.025mL

ACTIVE COMPARATOR

intravitreal injection in both eyes on Day 0, with up to 1 re-treatment allowed for each eye if required

Drug: Conbercept

Conbercept 0.15 mg/0.015mL

EXPERIMENTAL

intravitreal injection in both eyes on Day 0, with up to 1 re-treatment allowed for each eye if required

Drug: Conbercept

Interventions

Conbercept DRUG

Administered as an intravitreal injection

Conbercept 0.15 mg/0.015mL; Conbercept 0.25 mg/0.025mL

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Preterm infants with stage 4 or 5 ROP in one or both eyes
• Have received any previous surgical or nonsurgical treatment for ROP, including laser photocoagulation, anti-VEGF therapy, vitrectomy
• Have been previously exposed to any intravitreal or systemic anti-VEGF agent (either the patient or the mother during this child's pregnancy)
• 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
• Have active ocular infection within 5 days before or on the day of first investigational treatment
• Have a history of hypersensitivity (either the patient or the mother) to any of the investigational treatments or to drugs of similar chemical classes
• Have any contraindication for intravitreal injection clearly stated in the instructions
• Have any ocular structural abnormality that may affect efficacy assessments
• Have a history of any other congenital or systemic conditions that are assessed by the investigator to have a significant risk of severe impact on visual function
• 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

Sponsors & Collaborators

• Wang Yusheng: lead

Study Sites (3)

Department of Ophthalmology, the Second Affiliated Hospital of Xi'an Medical University

Xi'an, Shaanxi, 710032, China

RECRUITING

Department of Ophthalmology, Xijing Hospital, Air Force Military Medical University

Xi'an, Shaanxi, 710032, China

RECRUITING

Department of Ophthalmology, Xianyang Rainbow Hospital

Xianyang, Shaanxi, 712000, China

RECRUITING

MeSH Terms

Conditions

Retinopathy of Prematurity

Interventions

KH902 fusion protein

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Wang

CONTACT

02984771794; wangys003@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 28, 2024
• First Posted: December 5, 2024
• Study Start: November 29, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 4, 2025

Record last verified: 2024-11

Locations

CN (3)