Study Stopped
Due to inter-city travel restrictions for COVID-19, regular follow-up for most patients is not possible
Effects of Conbercept in Refractory Uveitic Macular Edema and VEGF
Effectiveness of Conbercept in Treating Refractory Uveitic Macular Edema and the Changes of VEGF Levels in the Aqueous Humor
1 other identifier
interventional
5
1 country
1
Brief Summary
As a primary exploratory study, this study aims to evaluate the short-term effectiveness of intravitreal Conbercept injection in UME, and to explore the correlation between inflammatory factors like VEGF and the responsiveness to treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Oct 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 12, 2019
CompletedFirst Submitted
Initial submission to the registry
January 1, 2020
CompletedFirst Posted
Study publicly available on registry
March 5, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 12, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 12, 2022
CompletedOctober 25, 2022
October 1, 2022
6 months
January 1, 2020
October 24, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Changes of best corrected visual acuity (BCVA)
changes from baseline BCVA at 1, 2, 3, 4, 5, 6 months after injection (at each follow-up visit)
baseline and at 1, 2, 3, 4, 5, 6 months after injection
Changes of central retinal thickness (CRT)
changes from baseline CRT at 1, 2, 3, 4, 5, 6 months after injection (at each follow-up visit)
baseline and at 1, 2, 3, 4, 5, 6 months after injection
Secondary Outcomes (4)
changes of concentration of inflammatory cytokines
before injection (baseline), 1 month after the first injection, at the end of the study (6 months)
inflammatory status
baseline and at 1, 2, 3, 4, 5, 6 months after injection
side effects of the eye: increase of intraocular pressure
baseline and at 1, 2, 3, 4, 5, 6 months after injection
side effects of the eye: development/exacerbation of cataract
baseline and at 1, 2, 3, 4, 5, 6 months after injection
Study Arms (1)
refractory UME patients treated with Conbercept
EXPERIMENTALpatients in this arm should meet the inclusion criteria and the definition of refractory UME
Interventions
patients will receive intravitreal injection of Conbercept, and at the same time, aqueous humor sample will be obtained from the anterior chamber to measure the concentrations of cytokines.
Eligibility Criteria
You may qualify if:
- age \>= 18 years old
- competent in signing the informed consent
- no severe systemic diseases unrelated to uveitis
- fulfill the criteria of refractory UME
You may not qualify if:
- pregnant or preparing pregnancy
- already in other clinical trials
- blood pressure \>= 180/110mmHg
- BCVA of the contralateral eye \<= 20/200
- cardiovascular events within 3 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Peking Union Medical College Hospital (PUMCH)
Beijing, Beijing Municipality, 100730, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 1, 2020
First Posted
March 5, 2020
Study Start
October 12, 2019
Primary Completion
April 12, 2020
Study Completion
February 12, 2022
Last Updated
October 25, 2022
Record last verified: 2022-10