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

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Exudative Age-Related Macular Degeneration
• Intervention / Treatment: Drug: different degrees of adjustment of the injection interval

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• China
  • Chongqing, China, 400016
    • The First Affiliated Hospital of Chongqing Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 2 week group; Drug injection adjustment interval is 2 weeks	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.; Other Names: Modified Treat-and-Extend Regimens
Experimental: 4 week group; Drug injection adjustment interval is 4 weeks	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.; Other Names: Modified Treat-and-Extend Regimens

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: First Affiliated Hospital of Chongqing Medical University
• Investigators: Study Chair: Hui Peng, PH.D, First Affiliated Hospital of Chongqing Medical University

Study record dates

Study Major Dates

• Study Start (Actual): November 12, 2018
• Primary Completion (Anticipated): August 1, 2023
• Study Completion (Anticipated): August 1, 2024

Study Registration Dates

• First Submitted: September 7, 2022
• First Submitted That Met QC Criteria: September 10, 2022
• First Posted (Actual): September 14, 2022

Study Record Updates

• Last Update Posted (Actual): September 14, 2022
• Last Update Submitted That Met QC Criteria: September 10, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Conbercept; Exudative age-related macular degeneration; anti-VEGF drug; Treat-and-extend
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration; Wet Macular Degeneration
• Other Study ID Numbers: HPeng

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Results available in the paper after publication

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No