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

Phase 2

• Conditions: Exudative Age-Related Macular Degeneration
• Interventions: Drug: different degrees of adjustment of the injection interval

• Registration Number: NCT05539235
• Lead Sponsor: First Affiliated Hospital of Chongqing Medical University

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.

Detailed Description

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.

Randomization and Interventions Conbercept (0.5 mg) was injected intravitreally once a month for 3 months, and then the patients were randomly divided into a 2-week group and a 4-week group. 2-week group: The injection interval was adjusted to 2 weeks. 4-week group: The injection interval was adjusted to 4 weeks. In the 2-week group, if the visual acuity decreased by less than 5 letters and the lesions showed no signs of exudative activity, such as rebleeding and increased oedema, the patients were followed up 6 weeks after the third injection and injected intravitreally once. If the condition remained stable, the follow-up was extended to 8 weeks , vitreous infusion was performed, and then the vitreous injection interval was gradually extended. If visual acuity decreased by more than 5 letters or the lesions showed rebleeding, increased oedema and other anatomical indicators worsened, a 4-week injection interval was maintained or reduced to 2 weeks based on the extended injection interval. In the 4-week group, the patients were followed up 8 weeks after the third injection and injected intravitreally once. If the condition remained stable, the follow-up was extended to 12 weeks, and vitreous injection was performed. Then, the vitreous injection interval was gradually extended.

Study Timeline

• Study Start: 2018-11-12
• Status Verified: 2022-09
• Study First Submitted: 2022-09-07
• Study First Submitted QC: 2022-09-10
• Last Update Submitted: 2022-09-10
• Study First Posted: 2022-09-14
• Last Update Posted: 2022-09-14
• Primary Completion: 2023-08-01
• Study Completion: 2024-08-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2 week group	different degrees of adjustment of the injection interval	Drug injection adjustment interval is 2 weeks
4 week group	different degrees of adjustment of the injection interval	Drug injection adjustment interval is 4 weeks

Primary Outcome Measures

Name	Time	Method
mean change of the best-corrected visual acuity	baseline, every time before pre-intervention	change of the best-corrected visual acuity

Secondary Outcome Measures

Name	Time	Method
mean number of injections	up to 2 years	number of injections
mean change of central retinal thickness	baseline, every time before pre-intervention	change of central retinal thickness
mean time of last injection interval	up to 2 years	last injection interval
the rate of complications or adverse reactions	up to 2 years	IOP, corneal epithelial defects, subconjunctival hemorrhage, secondary glaucoma, iatrogenic cataract, vitreous hemorrhage, endophthalmitis, systemic complications,

Trial Locations

Locations (1)

The First Affiliated Hospital of Chongqing Medical University; 🇨🇳 Chongqing, China