Efficacy and Safety of Intravitreal Conbercept With Modified Treat-and-Extend Regimens in Exudative AMD

NCT05539235 | Unknown Phase 2

• 1 other identifier: HPeng
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective study. Data from patients diagnosed with nAMD who have never received related treatment were collected. Treatment was an intravitreal injection of 0.5 mg conbercept using modified "T\&E" treatment plans. After three months of monthly intravitreal injections, the patients were randomly divided into two groups, and the degree of adjustment of the injection interval was divided into two weeks and four weeks. Unlike the ALTAIR study, we cancel the maintenance criteria of classical T\&E regimens. The best-corrected visual acuity (BCVA), central retinal thickness (CRT), last injection interval, and the number of injections were recorded at 3, 6, 12, and 24 months to evaluate treatment efficacy.

Conditions

Exudative Age-Related Macular Degeneration

Keywords

Exudative age-related macular degeneration; anti-VEGF drug; Treat-and-extend; Conbercept

Outcome Measures

Primary Outcomes (1)

• mean change of the best-corrected visual acuity

  change of the best-corrected visual acuity

  baseline, every time before pre-intervention

Secondary Outcomes (4)

• mean change of central retinal thickness

  baseline, every time before pre-intervention

• mean time of last injection interval

  up to 2 years

• mean number of injections

  up to 2 years

• the rate of complications or adverse reactions

  up to 2 years

Study Arms (2)

2 week group

EXPERIMENTAL

Drug injection adjustment interval is 2 weeks

Drug: different degrees of adjustment of the injection interval

4 week group

EXPERIMENTAL

Drug injection adjustment interval is 4 weeks

Drug: different degrees of adjustment of the injection interval

Interventions

different degrees of adjustment of the injection interval DRUG

Treatment was an intravitreal injection of 0.5 mg conbercept using modified "T\&E" treatment plans. After 3 months of monthly intravitreal injections, the patients were randomly divided into two groups, and the degree of adjustment of the injection interval was divided into 2 weeks and 4 weeks.

Also known as: Modified Treat-and-Extend Regimens

2 week group; 4 week group

Eligibility Criteria

• Age: 55 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age ≥50 years and meeting the diagnostic criteria for exudative AMD
• OCTA suggesting the presence of subretinal neovascularization
• no prior treatment (anti-VEGF, PDT, etc.)
• best-corrected visual acuity (BCVA) between 5-75 letters in the study eye.

You may not qualify if:

• allergy to drugs needed in the diagnosis and treatment
• a history of internal eye surgery (except surgery about cataract), trauma, or fundus laser photocoagulation
• other ophthalmologic diseases besides nAMD or cataracts
• renal insufficiency and severe cardiovascular and cerebrovascular diseases
• surgery required due to vitreous hemorrhage during follow-up treatment
• recent preparation for childbirth, pregnancy or lactation
• poor compliance with diagnosis and treatment or difficulty conducting a regular outpatient review and cooperating with treatment.

Sponsors & Collaborators

• First Affiliated Hospital of Chongqing Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Chongqing Medical University

Chongqing, 400016, China

Location

Related Publications (1)

• Xie H, Ju H, Lu J, Wang X, Peng H. Comparative study on the efficacy of Conbercept and Aflibercept in the treatment of neovascular age-related macular degeneration. Sci Rep. 2024 May 25;14(1):11997. doi: 10.1038/s41598-024-62536-8.

  PMID: 38796619 DERIVED

Study Officials

• Hui Peng, PH.D

  First Affiliated Hospital of Chongqing Medical University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Peng Hui, chief physician of Ophthalmology Department of the First Affiliated Hospital of Chongqing Medical University, randomly divided the enrolled patients into two groups when they only knew the patient number and did not know the specific situation of the patient.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: September 7, 2022
• First Posted: September 14, 2022
• Study Start: November 12, 2018
• Primary Completion: August 1, 2023
• Study Completion: August 1, 2024
• Last Updated: September 14, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)