Efficacy and Safety of Intravitreal Conbercept With Modified Treat-and-Extend Regimens in Exudative AMD (IIT-A)

Chongqing Medical University

Status and phase: Invitation-only; Phase 3; Phase 2

Conditions: Exudative Age-Related Macular Degeneration

Treatments: Drug: different degrees of adjustment of the injection interval

Study type: Interventional

Funder types: Other

Identifiers

NCT05539235

HPeng

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 55 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups

2 week group

Experimental group

Description:

Drug injection adjustment interval is 2 weeks

Treatment:

Drug: different degrees of adjustment of the injection interval

4 week group

Experimental group

Description:

Drug injection adjustment interval is 4 weeks

Treatment:

Drug: different degrees of adjustment of the injection interval