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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Efficacy and Safety of Intravitreal Conbercept With Modified Treat-and-Extend Regimens in Exudative Age-Related Macular Degeneration

Conditions
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Exudative Age-Related Macular Degeneration

Intervention / Treatment
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* Drug: different degrees of adjustment of the injection interval


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 2 week group<br>Drug injection adjustment interval is 2 weeks | Drug: different degrees of adjustment of the injection interval<br>* 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.<br>* Other names: Modified Treat-and-Extend Regimens;|
| Experimental: 4 week group<br>Drug injection adjustment interval is 4 weeks | Drug: different degrees of adjustment of the injection interval<br>* 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.<br>* Other names: Modified Treat-and-Extend Regimens;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mean change of the best-corrected visual acuity | change of the best-corrected visual acuity | baseline, every time before pre-intervention | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Conbercept, Exudative age-related macular degeneration, anti-VEGF drug, Treat-and-extend