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

Exudative Age-Related Macular Degeneration Clinical Trial

— IIT-A  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05539235
• Other study ID #: HPeng
• Status: Enrolling by invitation
• Phase: Phase 2/Phase 3
• Start date: November 12, 2018
• Est. completion date: August 1, 2024

Study information

• Verified date: September 2022
• Source: First Affiliated Hospital of Chongqing Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 60
• Est. completion date: August 1, 2024
• Est. primary completion date: August 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Exudative Age-Related Macular Degeneration
• Macular Degeneration
• Wet Macular Degeneration

Intervention

Drug:
• different degrees of adjustment of the injection interval
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.

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Chongqing Medical University	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital of Chongqing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mean change of the best-corrected visual acuity	change of the best-corrected visual acuity	baseline, every time before pre-intervention
Secondary	mean change of central retinal thickness	change of central retinal thickness	baseline, every time before pre-intervention
Secondary	mean time of last injection interval	last injection interval	up to 2 years
Secondary	mean number of injections	number of injections	up to 2 years
Secondary	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