Overview

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

Status:
Enrolling by invitation
Trial end date:
2024-08-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2/Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
First Affiliated Hospital of Chongqing Medical University
Criteria
Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.