Exudative Age-Related Macular DegenerationPhase 2/3IIT-ANCT05539235
Efficacy and Safety of Intravitreal Conbercept With Modified Treat-and-Extend Regimens in Exudative AMD
A Phase 2/3 study testing different degrees of adjustment of the injection interval in people with Exudative Age-Related Macular Degeneration, run by First Affiliated Hospital of Chongqing Medical University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 55 to 90 years
- Conditions the study is for
- Exudative Age-Related Macular Degeneration
- What is being tested?
- different degrees of adjustment of the injection interval
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 12 Nov 2018to 1 Aug 2024
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Chongqing Medical University
Chongqing, 400016
About this study
Official title: 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.
Read the 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.
- Being tested
- different degrees of adjustment of the injection interval
- Keywords
- Exudative age-related macular degeneration, anti-VEGF drug, Treat-and-extend, Conbercept
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
different degrees of adjustment of the injection intervalDrug
Also called Modified Treat-and-Extend Regimens
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.
| Study group | Role | What they receive |
|---|---|---|
| 2 week group | Experimental | Drug injection adjustment interval is 2 weeks Receives: Drug: different degrees of adjustment of the injection interval |
| 4 week group | Experimental | Drug injection adjustment interval is 4 weeks Receives: Drug: different degrees of adjustment of the injection interval |
What is being measured
The primary outcome is the main question the study is designed to answer.
mean change of the best-corrected visual acuity
change of the best-corrected visual acuity
Measured: baseline, every time before pre-intervention
Secondary outcomes (4)
mean change of central retinal thickness
change of central retinal thickness
Measured: baseline, every time before pre-intervention
mean time of last injection interval
last injection interval
Measured: up to 2 years
mean number of injections
number of injections
Measured: 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,
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2022
- Study start12 Nov 2018
- Primary completion1 Aug 2023 (estimated)
- Study completion1 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Exudative Age-Related Macular DegenerationStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Chongqing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hui Peng, First Affiliated Hospital of Chongqing Medical University
- Investigators
- Hui Peng, PH.D, Study chair, First Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05539235
- Sponsor's protocol ID
- HPeng
- Acronym
- IIT-A
- Status last verified
- Sep 2022
- First submitted
- 7 Sep 2022
- Last updated
- 14 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Results available in the paper after publication
Publications
Xie H, Ju H, Lu J, Wang X, Peng H. Comparative study on the efficacy of Conbercept and Aflibercept in the treatment of neovascular age-related macular degeneration. Sci Rep. 2024 May 25;14(1):11997. doi: 10.1038/s41598-024-62536-8.
PubMed 38796619
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Intravitreal Conbercept With Modified Treat-and-Extend Regimens in Exudative Age-Related Macular Degeneration
- ClinicalTrials.gov ID
- NCT05539235
- Acronym / sponsor ID
- IIT-A / HPeng
- Keywords
- Exudative age-related macular degeneration, anti-VEGF drug, Treat-and-extend, Conbercept
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Chongqing Medical UniversityUniversity, hospital or other
- Study start
- 12 Nov 2018 (actual)
- Primary completion
- 1 Aug 2023 (estimated)
- Study completion
- 1 Aug 2024 (estimated)
- First posted
- 14 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 week group | Experimental | Drug: different degrees of adjustment of the injection intervalDrug injection adjustment interval is 2 weeks |
| 4 week group | Experimental | Drug: different degrees of adjustment of the injection intervalDrug injection adjustment interval is 4 weeks |
Who may qualify
- Ages
- 55 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| different degrees of adjustment of the injection intervalAlso: Modified Treat-and-Extend RegimensTreatment 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. | Drug | 2 week group, 4 week group |
Primary outcome
mean change of the best-corrected visual acuity
Time frame: baseline, every time before pre-intervention
change of the best-corrected visual acuity
4 secondary outcomes
mean change of central retinal thickness
Time frame: baseline, every time before pre-intervention
mean time of last injection interval
Time frame: up to 2 years
mean number of injections
Time frame: up to 2 years
the rate of complications or adverse reactions
Time frame: up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2022.
- Derived from this study: PubMed 38796619Xie H, Ju H, Lu J, Wang X, Peng H. Comparative study on the efficacy of Conbercept and Aflibercept in the treatment of neovascular age-related macular degeneration. Sci Rep. 2024 May 25;14(1):11997. doi: 10.1038/s41598-024-62536-8.
- Individual participant dataSharing planned: No. Results available in the paper after publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hui Peng, PH.D study chair
First Affiliated Hospital of Chongqing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing different degrees of adjustment of the injection interval in people with Exudative Age-Related Macular Degeneration, run by First Affiliated Hospital of Chongqing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mean change of the best-corrected visual acuity (time frame: baseline, every time before pre-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05539235, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2022.