Clinical trial NCT05539235: Efficacy and Safety of Intravitreal Conbercept With Modified Treat-and-Extend Regimens in Exudative AMD
Official title: Efficacy and Safety of Intravitreal Conbercept With Modified Treat-and-Extend Regimens in Exudative Age-Related Macular Degeneration
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Exudative Age-Related Macular Degeneration
Keywords: Exudative age-related macular degeneration
anti-VEGF drug
Treat-and-extend
Conbercept
Lead sponsor: First Affiliated Hospital of Chongqing Medical University
Sponsor class: OTHER
First posted: 2022-09-14
Enrollment: 60
Sex: ALL
Minimum age (years): 55
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: mean change of the best-corrected visual acuity
timeFrame: baseline, every time before pre-intervention
Secondary outcomes:
measure: mean change of central retinal thickness
timeFrame: baseline, every time before pre-intervention
measure: mean time of last injection interval
timeFrame: up to 2 years
measure: mean number of injections
timeFrame: up to 2 years
measure: the rate of complications or adverse reactions
timeFrame: up to 2 years
Other outcomes:
Locations:
city: Chongqing
country: China
facility: The First Affiliated Hospital of Chongqing Medical University
Study officials:
affiliation: First Affiliated Hospital of Chongqing Medical University
name: Hui Peng, PH.D
role: STUDY_CHAIR
References: