Efficacy and Safety of Intravitreal Conbercept With Modified Treat-and-Extend Regimens in Exudative AMD (IIT-A)
Primary Purpose
Exudative Age-Related Macular Degeneration
Status
Enrolling by invitation
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
different degrees of adjustment of the injection interval
Sponsored by
About this trial
This is an interventional treatment trial for Exudative Age-Related Macular Degeneration focused on measuring Exudative age-related macular degeneration, anti-VEGF drug, Treat-and-extend, Conbercept
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.
Sites / Locations
- The First Affiliated Hospital of Chongqing Medical University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
2 week group
4 week group
Arm Description
Drug injection adjustment interval is 2 weeks
Drug injection adjustment interval is 4 weeks
Outcomes
Primary Outcome Measures
mean change of the best-corrected visual acuity
change of the best-corrected visual acuity
Secondary Outcome Measures
mean change of central retinal thickness
change of central retinal thickness
mean time of last injection interval
last injection interval
mean number of injections
number of injections
the rate of complications or adverse reactions
IOP, corneal epithelial defects, subconjunctival hemorrhage, secondary glaucoma, iatrogenic cataract, vitreous hemorrhage, endophthalmitis, systemic complications,
Full Information
NCT ID
NCT05539235
First Posted
September 7, 2022
Last Updated
September 10, 2022
Sponsor
First Affiliated Hospital of Chongqing Medical University
1. Study Identification
Unique Protocol Identification Number
NCT05539235
Brief Title
Efficacy and Safety of Intravitreal Conbercept With Modified Treat-and-Extend Regimens in Exudative AMD
Acronym
IIT-A
Official Title
Efficacy and Safety of Intravitreal Conbercept With Modified Treat-and-Extend Regimens in Exudative Age-Related Macular Degeneration
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
November 12, 2018 (Actual)
Primary Completion Date
August 1, 2023 (Anticipated)
Study Completion Date
August 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
First Affiliated Hospital of Chongqing Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Exudative Age-Related Macular Degeneration
Keywords
Exudative age-related macular degeneration, anti-VEGF drug, Treat-and-extend, Conbercept
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Peng Hui, chief physician of Ophthalmology Department of the First Affiliated Hospital of Chongqing Medical University, randomly divided the enrolled patients into two groups when they only knew the patient number and did not know the specific situation of the patient.
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
2 week group
Arm Type
Experimental
Arm Description
Drug injection adjustment interval is 2 weeks
Arm Title
4 week group
Arm Type
Experimental
Arm Description
Drug injection adjustment interval is 4 weeks
Intervention Type
Drug
Intervention Name(s)
different degrees of adjustment of the injection interval
Other Intervention Name(s)
Modified Treat-and-Extend Regimens
Intervention Description
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.
Primary Outcome Measure Information:
Title
mean change of the best-corrected visual acuity
Description
change of the best-corrected visual acuity
Time Frame
baseline, every time before pre-intervention
Secondary Outcome Measure Information:
Title
mean change of central retinal thickness
Description
change of central retinal thickness
Time Frame
baseline, every time before pre-intervention
Title
mean time of last injection interval
Description
last injection interval
Time Frame
up to 2 years
Title
mean number of injections
Description
number of injections
Time Frame
up to 2 years
Title
the rate of complications or adverse reactions
Description
IOP, corneal epithelial defects, subconjunctival hemorrhage, secondary glaucoma, iatrogenic cataract, vitreous hemorrhage, endophthalmitis, systemic complications,
Time Frame
up to 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hui Peng, PH.D
Organizational Affiliation
First Affiliated Hospital of Chongqing Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
The First Affiliated Hospital of Chongqing Medical University
City
Chongqing
ZIP/Postal Code
400016
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Results available in the paper after publication
Learn more about this trial
Efficacy and Safety of Intravitreal Conbercept With Modified Treat-and-Extend Regimens in Exudative AMD
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