Antiangiogenic Therapy of CNV Associated With Angioid Streaks
COAST_UAasCNV
Collaborative Ocular Antiangiogenic Study of Ukraine. Multicentral, Open-label, Randomized, Prospective Study of Antiangiogenic Therapy of Choroidal Neovascularisation Associated With Angioid Streaks
1 other identifier
interventional
100
1 country
3
Brief Summary
The purpose of this study is to determine the effectiveness of antiangiogenic therapy to choroidal neovascularization secondary to angioid streaks.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2018
Longer than P75 for not_applicable
3 active sites
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
March 27, 2018
CompletedFirst Submitted
Initial submission to the registry
October 7, 2019
CompletedFirst Posted
Study publicly available on registry
October 8, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2022
CompletedFebruary 3, 2021
February 1, 2021
3.8 years
October 7, 2019
February 2, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean Change in Best Corrected Visual Acuity (BCVA) as Measured by ETDRS Chart
Defined study baseline range of ETDRS equivalent of 20/200 to 20/20) in the study eye; a higher score represents better functioning.
Baseline-Month 12
Secondary Outcomes (3)
Mean Change in Central Retinal Thickness (CRT) as Assessed by Optical Coherence Tomography (OCT)
Baseline-Month 12
Average Number of Intravitreal Injections
Baseline-Month 12
Number of Endophthalmitis after Intravitreal Injections
Baseline-Month 12
Study Arms (2)
Ranibizumab
ACTIVE COMPARATORArm 1
Aflibercept
ACTIVE COMPARATORArm 2
Interventions
Intravitreal injection to the regimen pro re nata.
Eligibility Criteria
You may qualify if:
- Able to read (or, if unable to read due to visual impairment, be read to verbatim by the person administering the informed consent form or a family member) and understand the informed consent form and willing to sign the informed consent form.
- Signed informed consent form.
- Men and women ≥ 18 years of age.
- Willing, committed, and able to return for all clinic visits and complete all study-related procedures.
- First diagnosed active subfoveal or juxtafoveal (within 1 to 199 μm of the center of the fovea) CNV secondary to angioid streaks as defined by leakage on FA
- Transparent optical media and possibility to mydriasis.
- Best corrected visual acuity at least 20/100 Equivalent of Snellen (ETDRS).
You may not qualify if:
- Ocular media of insufficient quality to obtain fundus and OCT images in the study eye.
- Recurrent CNV in the study eye.
- History or presence of CNV with an origin other than angioid streaks in the study eye.
- Ocular inflammation or external ocular inflammation in the study eye. 5 Concurrent disease in the study eye that would compromise BCVA or require medical or surgical intervention during the study period.
- \. Any ocular disorder in the study eye that, in the opinion of the investigator, may confound interpretation of the study results.
- \. Significant scarring or atrophy in the fovea that indicates substantial irreversible vision loss in the study eye.
- \. Evidence at examination of infectious blepharitis, keratitis, scleritis, or conjunctivitis in either eye or current treatment for serious systemic infection.
- \. Vitreomacular traction or traction retinal detachment, epiretinal membrane in either eye.
- \. Any iris neovascularization and/or vitreous hemorrhage in either eye. 11. Uncontrolled glaucoma, or previous filtration surgery in either eye. 12. Any prior or concomitant treatment with another investigational agent for CNV in the study eye.
- \. Any previous panretinal photocoagulation or subfoveal thermal laser therapy in the study eye.
- \. Any prior treatment with photodynamic therapy in the study eye. 15. Cataract surgery within 3 months prior to Day 1 in the study eye. 16. Yttrium-aluminum-garnet laser capsulotomy within 2 months prior to Day 1 in the study eye.
- \. Any other intraocular surgery within 3 months prior to Day 1 in the study eye.
- \. History of vitreoretinal surgery and/or scleral buckle surgery in the study eye.
- \. Any prior treatment with anti-VEGF agents. 20. Previous use of intraocular or periocular corticosteroids in either eye within 3 months prior to Day 1.
- \. Previous assignment to treatment during this study. 22. Uncontrolled hypertension. 23. History of cerebrovascular disease or myocardial infarction within 6 months prior to Baseline/Day 1.
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Mykolaiv Region Ophthalmogical Hospital
Mykolaiv, 54000, Ukraine
Odessa National Medical University
Odesa, 65028, Ukraine
The Filatov Institute of Eye Diseases and Tissue Therapy
Odesa, 65061, Ukraine
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andrii MD Korol, PhD
The Filatov Institute of Eye Diseases and Tissue Therapy
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of Laser Department
Study Record Dates
First Submitted
October 7, 2019
First Posted
October 8, 2019
Study Start
March 27, 2018
Primary Completion
December 31, 2021
Study Completion
January 31, 2022
Last Updated
February 3, 2021
Record last verified: 2021-02
Data Sharing
- IPD Sharing
- Will not share