Neovascular Age-related Macular EdemaNCT05222633
Anti-VEGF in Real-world
An observational study of Neovascular Age-related Macular Edema and Diabetic Macular Edema, run by Wenbin Wei at 1 site in China.
Trial summary
Anti-vascular endothelial growth factor therapy is the major intervention for treating ischemic retina diseases. According to FDA and China Food and Drug Administration, Ranibizumab, Aflibercept, and Conbercept are major types of anti-vascular endothelial growth factor therapy drugs. Read more about this study
- Who is it for?
- Ages 35 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Neovascular Age-related Macular Edema, Diabetic Macular Edema, Choroidal Neovascular Membrane
- What is being tested?
- Ranibizumab, Aflibercept and Conbercept
- Type of treatment
- Injection or infusion
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2022to 1 May 2023
- Phase
- Observational
- 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 35 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with neovascular age-related macular edema (nAMD), diabetic macula edema (DME)/non-proliferative diabetic retinopathy (NPDR)/ proliferative diabetic retinopathy (PDR), retinal vein occlusions related macular edema, and choroidal neovascular (CNV) secondary to multiple retinal diseases.
Who may be able to join
- Patients with neovascular age-related macular edema (nAMD), diabetic macula edema (DME)/non-proliferative diabetic retinopathy (NPDR)/ proliferative diabetic retinopathy (PDR), retinal vein occlusions related macular edema, and choroidal neovascular (CNV) secondary to multiple retinal diseases.
- Undergo intravitreal anti-VEGF therapy
Who cannot join
- unable to receive OCT examination
- Severe corneal opacity, cataract that affect OCT examination
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Wen-Bin Wei
Beijing, Beijing Municipality, 100730
Wen-Bin Wei, MD, weiwenbintr@163.com
Wen-Bin Wei, MD
About this study
Official title: Observation of Anti-vascular Endothelial Growth Factor Therapy in Exudative Age-related Macular Degeneration, Proliferative Diabetic Retinopathy, Macular Edema, and Choroidal Neovascularization.
Anti-vascular endothelial growth factor therapy is the major intervention for treating ischemic retina diseases. According to FDA and China Food and Drug Administration, Ranibizumab, Aflibercept, and Conbercept are major types of anti-vascular endothelial growth factor therapy drugs. In the current study, the primary aim is to observe the visual acuity, anatomy effect of anti-vascular endothelial growth factor therapy in the real-world setting.
Read the detailed description
Anti-vascular endothelial growth factor therapy is the major intervention for treating ischemic retina diseases, including neovascular age-related macular edema, diabetic macula edema/non-proliferative diabetic retinopathy / proliferative diabetic retinopathy, retinal vein occlusions related macular edema, and choroidal neovascularization secondary to multiple retinal diseases. According to FDA and China Food and Drug Administration, Ranibizumab, Aflibercept, and Conbercept are major types of anti-VEGF drugs. In the current study, the primary aim is to aim to observe the visual acuity, anatomy effect of anti-vascular endothelial growth factor therapy in the real-world setting.
- Conditions
- Neovascular Age-related Macular Edema, Diabetic Macular Edema, Choroidal Neovascular Membrane, Non-proliferative Diabetic Retinopathy, Retinal Vein Occlusion, Proliferative Diabetic Retinopathy
- Being tested
- Ranibizumab, Aflibercept, Conbercept
- Medical subject headings
- Retinal Vein Occlusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RanibizumabDrug
Ranibizumab 0.5mg/0.05ml intravitreal injection
AfliberceptDrug
Aflibercept 2.0mg/0.05ml intravitreal injection
ConberceptDrug
Conbercept 0.5mg/0.05ml intravitreal injection
| Study group | Role | What they receive |
|---|---|---|
| Neovascular age-related macular edema | Patients with new-onset and recurrent Neovascular age-related macular edema. Receives: Drug: Ranibizumab; Drug: Aflibercept; Drug: Conbercept | |
| Diabetic macula edema | Patients with new-onset and recurrent diabetic macula edema Receives: Drug: Ranibizumab; Drug: Aflibercept; Drug: Conbercept | |
| Non-proliferative diabetic retinopathy/proliferative diabetic retinopathy | Patients with new-onset and recurrent non-proliferative diabetic retinopathy/proliferative diabetic retinopathy Receives: Drug: Ranibizumab; Drug: Aflibercept; Drug: Conbercept | |
| Retinal vein occlusions | Patients with new-onset and recurrent retinal vein occlusions Receives: Drug: Ranibizumab | |
| Choroidal neovascularization | Patients with new-onset and recurrent choroidal neovascularization Receives: Drug: Ranibizumab; Drug: Aflibercept; Drug: Conbercept |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual acuity
LogMAR visual acuity
Measured: 1 year
Central subfield thickness
he central subfield is defined as the circular area 1 mm in diameter centered around the center point of the fovea
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2022
- Study start1 Jan 2022
- Primary completion1 Jan 2023 (estimated)
- Study completion1 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neovascular Age-related Macular EdemaStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wenbin Wei
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Wenbin Wei, Beijing Tongren Hospital
- Investigators
- Wenbin Wei, MD, Study director, Beijing Tongren Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05222633
- Sponsor's protocol ID
- Anti-VEGF in real-world
- Status last verified
- Feb 2022
- First submitted
- 25 Dec 2021
- Last updated
- 3 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observation of Anti-vascular Endothelial Growth Factor Therapy in Exudative Age-related Macular Degeneration, Proliferative Diabetic Retinopathy, Macular Edema, and Choroidal Neovascularization.
- ClinicalTrials.gov ID
- NCT05222633
- Acronym / sponsor ID
- Anti-VEGF in real-world
- Conditions
- Neovascular Age-related Macular Edema, Diabetic Macular Edema, Choroidal Neovascular Membrane, Non-proliferative Diabetic Retinopathy, Retinal Vein Occlusion, Proliferative Diabetic Retinopathy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Wenbin WeiUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Jan 2023 (estimated)
- Study completion
- 1 May 2023 (estimated)
- First posted
- 3 Feb 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.
Anti-vascular endothelial growth factor therapy is the major intervention for treating ischemic retina diseases. According to FDA and China Food and Drug Administration, Ranibizumab, Aflibercept, and Conbercept are major types of anti-vascular endothelial growth factor therapy drugs. In the current study, the primary aim is to observe the visual acuity, anatomy effect of anti-vascular endothelial growth factor therapy in the real-world setting.
Detailed description
Anti-vascular endothelial growth factor therapy is the major intervention for treating ischemic retina diseases, including neovascular age-related macular edema, diabetic macula edema/non-proliferative diabetic retinopathy / proliferative diabetic retinopathy, retinal vein occlusions related macular edema, and choroidal neovascularization secondary to multiple retinal diseases. According to FDA and China Food and Drug Administration, Ranibizumab, Aflibercept, and Conbercept are major types of anti-VEGF drugs. In the current study, the primary aim is to aim to observe the visual acuity, anatomy effect of anti-vascular endothelial growth factor therapy in the real-world setting.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Neovascular age-related macular edema | – | Drug: Ranibizumab, Drug: Aflibercept, Drug: ConberceptPatients with new-onset and recurrent Neovascular age-related macular edema. |
| Diabetic macula edema | – | Drug: Ranibizumab, Drug: Aflibercept, Drug: ConberceptPatients with new-onset and recurrent diabetic macula edema |
| Non-proliferative diabetic retinopathy/proliferative diabetic retinopathy | – | Drug: Ranibizumab, Drug: Aflibercept, Drug: ConberceptPatients with new-onset and recurrent non-proliferative diabetic retinopathy/proliferative diabetic retinopathy |
| Retinal vein occlusions | – | Drug: RanibizumabPatients with new-onset and recurrent retinal vein occlusions |
| Choroidal neovascularization | – | Drug: Ranibizumab, Drug: Aflibercept, Drug: ConberceptPatients with new-onset and recurrent choroidal neovascularization |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with neovascular age-related macular edema (nAMD), diabetic macula edema (DME)/non-proliferative diabetic retinopathy (NPDR)/ proliferative diabetic retinopathy (PDR), retinal vein occlusions related macular edema, and choroidal neovascular (CNV) secondary to multiple retinal diseases.
Key inclusion criteria (2 listed)
- Patients with neovascular age-related macular edema (nAMD), diabetic macula edema (DME)/non-proliferative diabetic retinopathy (NPDR)/ proliferative diabetic retinopathy (PDR), retinal vein occlusions related macular edema, and choroidal neovascular (CNV) secondary to multiple retinal diseases.
- Undergo intravitreal anti-VEGF therapy
Key exclusion criteria (2 listed)
- unable to receive OCT examination
- Severe corneal opacity, cataract that affect OCT examination
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 |
|---|---|---|
| RanibizumabRanibizumab 0.5mg/0.05ml intravitreal injection | Drug | Choroidal neovascularization, Diabetic macula edema, Neovascular age-related macular edema, Non-proliferative diabetic retinopathy/proliferative diabetic retinopathy, Retinal vein occlusions |
| AfliberceptAflibercept 2.0mg/0.05ml intravitreal injection | Drug | Choroidal neovascularization, Diabetic macula edema, Neovascular age-related macular edema, Non-proliferative diabetic retinopathy/proliferative diabetic retinopathy |
| ConberceptConbercept 0.5mg/0.05ml intravitreal injection | Drug | Choroidal neovascularization, Diabetic macula edema, Neovascular age-related macular edema, Non-proliferative diabetic retinopathy/proliferative diabetic retinopathy |
Primary outcome
Visual acuity
Time frame: 1 year
LogMAR visual acuity
Central subfield thickness
Time frame: 1 year
he central subfield is defined as the circular area 1 mm in diameter centered around the center point of the fovea
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Neovascular Age-related Macular Edema
RecruitingPhase 2
A Dose-masked Study of Intravitreal Remigromig (EYE103) in Participants With NVAMD or Macular Edema Following BRVO
Neovascular Age-Related Macular Degeneration (NVAMD), Branch Retinal Vein Occlusion (BRVO)
Active, not recruitingObservational study
A Real-World Study to Gain Clinical Insights Into Faricimab (FaReal Study)
Neovascular Age-related Macular Degeneration, Diabetic Macular Edema
Active, not recruitingObservational study
A Real-World Study to Gain Clinical Insights Into Roche Ophthalmology Products
Neovascular Age-related Macular Degeneration, Diabetic Macular Edema
Not yet recruitingObservational study
MIND-AMD Study: a Multidisciplinary Investigation of Neuroretinal Damage in Age-related Macular Degeneration.
Age-Related (Dry) Macular Degeneration, Age-Related Macular Degeneration (AMD)
Active, not recruiting
Speculum-Free Intravitreal Injection Using Cotton-Tipped Applicator Retraction: Pain, Procedure Time, Patient Satisfaction, and Safety
Neovascular Age-Related Macular Degeneration (nAMD), Diabetic Macular Edema
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.
Wenbin Wei, MD study director
Beijing Tongren Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neovascular Age-related Macular Edema and Diabetic Macular Edema, run by Wenbin Wei 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 2 inclusion and 2 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 3 Feb 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.
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?
Contact Wenbin Wei, MD (010-58269523, weiwenbintr@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual acuity (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Feb 2022.