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Antiangiogenic Therapy of CNV Associated With Angioid Streaks (COAST_UAasCNV)

Primary Purpose

Angioid Streaks of Macula

Status
Unknown status
Phase
Not Applicable
Locations
Ukraine
Study Type
Interventional
Intervention
Intravitreal injection
Sponsored by
The Filatov Institute of Eye Diseases and Tissue Therapy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Angioid Streaks of Macula focused on measuring fundus diseases, antiangiogenic therapy, subretinal neovascular membrane, intravitreal injection, anti-VEGF, angioid streaks

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Inclusion Criteria:

    1. 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.
    2. Signed informed consent form.
    3. Men and women ≥ 18 years of age.
    4. Willing, committed, and able to return for all clinic visits and complete all study-related procedures.
    5. 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
    6. Transparent optical media and possibility to mydriasis.
    7. Best corrected visual acuity at least 20/100 Equivalent of Snellen (ETDRS).
  • Exclusion Criteria:

    1. Ocular media of insufficient quality to obtain fundus and OCT images in the study eye.
    2. Recurrent CNV in the study eye.
    3. History or presence of CNV with an origin other than angioid streaks in the study eye.
    4. 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.

    6. Any ocular disorder in the study eye that, in the opinion of the investigator, may confound interpretation of the study results.

    7. Significant scarring or atrophy in the fovea that indicates substantial irreversible vision loss in the study eye.

    8. Evidence at examination of infectious blepharitis, keratitis, scleritis, or conjunctivitis in either eye or current treatment for serious systemic infection.

    9. Vitreomacular traction or traction retinal detachment, epiretinal membrane in either eye.

    10. 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.

    13. Any previous panretinal photocoagulation or subfoveal thermal laser therapy in the study eye.

    14. 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.

    17. Any other intraocular surgery within 3 months prior to Day 1 in the study eye.

    18. History of vitreoretinal surgery and/or scleral buckle surgery in the study eye.

    19. 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.

    21. 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.

    24. History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug, may affect interpretation of the results of the study, or renders the subject at high risk from treatment complications.

    25. Women of childbearing potential without contraception, women who intend to breastfeed during the study. All subjects (both men and women) of childbearing potential who are unwilling to use adequate birth control measures during the course of the study.

    26. Renal failure requiring dialysis or renal transplant. 27. Participation in an investigational study within 30 days prior to Screening/Visit 1 that involved treatment with any drug (excluding vitamins and minerals) or device.

    28. Known serious allergy to the fluorescein sodium for injection in angiography or Verteporfin.

    29. Inability to obtain fundus photographs or fluorescein angiograms of sufficient quality

Sites / Locations

  • Mykolaiv Region Ophthalmogical HospitalRecruiting
  • Odessa National Medical UniversityRecruiting
  • The Filatov Institute of Eye Diseases and Tissue TherapyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Ranibizumab

Aflibercept

Arm Description

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Mean Change in Central Retinal Thickness (CRT) as Assessed by Optical Coherence Tomography (OCT)
A negative number indicates improvement (reduced thickness).
Average Number of Intravitreal Injections
The number of intravitreal injections administered
Number of Endophthalmitis after Intravitreal Injections
The number of endophthalmitis registered in patients after intravitreal injections

Full Information

First Posted
October 7, 2019
Last Updated
February 2, 2021
Sponsor
The Filatov Institute of Eye Diseases and Tissue Therapy
Collaborators
Odessa National Medical University, Mykolaiv Region Ophthalmogical Hospital, Central Polyclinic of Internal Affairs of Ukraine
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1. Study Identification

Unique Protocol Identification Number
NCT04119219
Brief Title
Antiangiogenic Therapy of CNV Associated With Angioid Streaks
Acronym
COAST_UAasCNV
Official Title
Collaborative Ocular Antiangiogenic Study of Ukraine. Multicentral, Open-label, Randomized, Prospective Study of Antiangiogenic Therapy of Choroidal Neovascularisation Associated With Angioid Streaks
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 27, 2018 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
January 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Filatov Institute of Eye Diseases and Tissue Therapy
Collaborators
Odessa National Medical University, Mykolaiv Region Ophthalmogical Hospital, Central Polyclinic of Internal Affairs of Ukraine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine the effectiveness of antiangiogenic therapy to choroidal neovascularization secondary to angioid streaks.
Detailed Description
The purpose of this study is to determine the effectiveness of antiangiogenic therapy to choroidal neovascularization secondary to angioid streaks. This study is planned as a follow-up. Patients with angioid streaks included in it will receive antiangiogenic therapy in accordance with the approved indications for use indicated in the instructions for the use of drugs in Ukraine. The treatment proposed in this study is based on the world experience and scientific developments of the Filatov Institute of Eye Diseases and Tissue Therapy of the NAMS of Ukraine ". Therefore, it is expected that the benefit / risk ratio in relation to the participation in this study should not be different from that described in the scientific literature and the benefits outweigh the risk. It is known that the absence of treatment in these diseases leads to an irreparable loss of central vision.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Angioid Streaks of Macula
Keywords
fundus diseases, antiangiogenic therapy, subretinal neovascular membrane, intravitreal injection, anti-VEGF, angioid streaks

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ranibizumab
Arm Type
Active Comparator
Arm Description
Arm 1
Arm Title
Aflibercept
Arm Type
Active Comparator
Arm Description
Arm 2
Intervention Type
Procedure
Intervention Name(s)
Intravitreal injection
Other Intervention Name(s)
Patients after general ophthalmic examination (visometry, refractometry, biomicroscopy, ophthalmoscopy, OCT, fluorescent angiography) receive an injection according to the regimen pro re nata.
Intervention Description
Intravitreal injection to the regimen pro re nata.
Primary Outcome Measure Information:
Title
Mean Change in Best Corrected Visual Acuity (BCVA) as Measured by ETDRS Chart
Description
Defined study baseline range of ETDRS equivalent of 20/200 to 20/20) in the study eye; a higher score represents better functioning.
Time Frame
Baseline-Month 12
Secondary Outcome Measure Information:
Title
Mean Change in Central Retinal Thickness (CRT) as Assessed by Optical Coherence Tomography (OCT)
Description
A negative number indicates improvement (reduced thickness).
Time Frame
Baseline-Month 12
Title
Average Number of Intravitreal Injections
Description
The number of intravitreal injections administered
Time Frame
Baseline-Month 12
Title
Number of Endophthalmitis after Intravitreal Injections
Description
The number of endophthalmitis registered in patients after intravitreal injections
Time Frame
Baseline-Month 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Inclusion Criteria: 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). Exclusion Criteria: 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. 6. Any ocular disorder in the study eye that, in the opinion of the investigator, may confound interpretation of the study results. 7. Significant scarring or atrophy in the fovea that indicates substantial irreversible vision loss in the study eye. 8. Evidence at examination of infectious blepharitis, keratitis, scleritis, or conjunctivitis in either eye or current treatment for serious systemic infection. 9. Vitreomacular traction or traction retinal detachment, epiretinal membrane in either eye. 10. 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. 13. Any previous panretinal photocoagulation or subfoveal thermal laser therapy in the study eye. 14. 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. 17. Any other intraocular surgery within 3 months prior to Day 1 in the study eye. 18. History of vitreoretinal surgery and/or scleral buckle surgery in the study eye. 19. 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. 21. 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. 24. History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug, may affect interpretation of the results of the study, or renders the subject at high risk from treatment complications. 25. Women of childbearing potential without contraception, women who intend to breastfeed during the study. All subjects (both men and women) of childbearing potential who are unwilling to use adequate birth control measures during the course of the study. 26. Renal failure requiring dialysis or renal transplant. 27. Participation in an investigational study within 30 days prior to Screening/Visit 1 that involved treatment with any drug (excluding vitamins and minerals) or device. 28. Known serious allergy to the fluorescein sodium for injection in angiography or Verteporfin. 29. Inability to obtain fundus photographs or fluorescein angiograms of sufficient quality
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andrii MD Korol, PhD
Phone
+380936327266
Email
andrii.r.korol@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Viktoriia MD Rostel
Phone
+380976126589
Email
rostelviktoria@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrii MD Korol, PhD
Organizational Affiliation
The Filatov Institute of Eye Diseases and Tissue Therapy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mykolaiv Region Ophthalmogical Hospital
City
Mykolaiv
ZIP/Postal Code
54000
Country
Ukraine
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Krasymira Rylkovа, PhD
Facility Name
Odessa National Medical University
City
Odessa
ZIP/Postal Code
65028
Country
Ukraine
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nadiia Ulianova, PhD
Facility Name
The Filatov Institute of Eye Diseases and Tissue Therapy
City
Odessa
ZIP/Postal Code
65061
Country
Ukraine
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

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Antiangiogenic Therapy of CNV Associated With Angioid Streaks

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