NCT05222633

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 25, 2021

Completed
7 days until next milestone

Study Start

First participant enrolled

January 1, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 3, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2023

Completed
Last Updated

February 3, 2022

Status Verified

February 1, 2022

Enrollment Period

1 year

First QC Date

December 25, 2021

Last Update Submit

February 2, 2022

Conditions

Neovascular Age-related Macular EdemaDiabetic Macular EdemaChoroidal Neovascular MembraneNon-proliferative Diabetic RetinopathyRetinal Vein OcclusionProliferative Diabetic Retinopathy

Outcome Measures

Primary Outcomes (2)

  • Visual acuity

    LogMAR visual acuity

    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

    1 year

Study Arms (5)

Neovascular age-related macular edema

Patients with new-onset and recurrent Neovascular age-related macular edema.

Drug: RanibizumabDrug: AfliberceptDrug: Conbercept

Diabetic macula edema

Patients with new-onset and recurrent diabetic macula edema

Drug: RanibizumabDrug: AfliberceptDrug: Conbercept

Non-proliferative diabetic retinopathy/proliferative diabetic retinopathy

Patients with new-onset and recurrent non-proliferative diabetic retinopathy/proliferative diabetic retinopathy

Drug: RanibizumabDrug: AfliberceptDrug: Conbercept

Retinal vein occlusions

Patients with new-onset and recurrent retinal vein occlusions

Drug: Ranibizumab

Choroidal neovascularization

Patients with new-onset and recurrent choroidal neovascularization

Drug: RanibizumabDrug: AfliberceptDrug: Conbercept

Interventions

RanibizumabDRUG

Ranibizumab 0.5mg/0.05ml intravitreal injection

Choroidal neovascularizationDiabetic macula edemaNeovascular age-related macular edemaNon-proliferative diabetic retinopathy/proliferative diabetic retinopathyRetinal vein occlusions
AfliberceptDRUG

Aflibercept 2.0mg/0.05ml intravitreal injection

Choroidal neovascularizationDiabetic macula edemaNeovascular age-related macular edemaNon-proliferative diabetic retinopathy/proliferative diabetic retinopathy
ConberceptDRUG

Conbercept 0.5mg/0.05ml intravitreal injection

Choroidal neovascularizationDiabetic macula edemaNeovascular age-related macular edemaNon-proliferative diabetic retinopathy/proliferative diabetic retinopathy

Eligibility Criteria

Age35 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • unable to receive OCT examination
  • Severe corneal opacity, cataract that affect OCT examination

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wen-Bin Wei

Beijing, Beijing Municipality, 100730, China

RECRUITING

MeSH Terms

Conditions

Retinal Vein Occlusion

Interventions

RanibizumabafliberceptKH902 fusion protein

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesVenous ThrombosisThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Wenbin Wei, MD

    Beijing Tongren Hospital

    STUDY DIRECTOR

Central Study Contacts

Wenbin Wei, MD

CONTACT

010-58269523weiwenbintr@163.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

December 25, 2021

First Posted

February 3, 2022

Study Start

January 1, 2022

Primary Completion

January 1, 2023

Study Completion

May 1, 2023

Last Updated

February 3, 2022

Record last verified: 2022-02

Locations

CN(1)