Antiangiogenic Therapy of Choroidal Neovascularisation Associated With Myopia (COAST_UAmCNV)

• ClinicalTrials.gov Identifier: NCT03963596
• Recruitment Status: Recruiting
• First Posted: May 24, 2019
• Last Update Posted: April 27, 2020
• 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
• Information provided by (Responsible Party): Andrii Korol, MD, PhD, The Filatov Institute of Eye Diseases and Tissue Therapy

Study Description

Brief Summary:

The purpose of this study is to determine the effectiveness of antiangiogenic therapy to choroidal neovascularization secondary to pathologic myopia.

Condition or disease	Intervention/treatment	Phase
Pathologic Myopia	Procedure: Intravitreal injection	Not Applicable

Detailed Description:

The purpose of this study is to determine the effectiveness of antiangiogenic therapy to choroidal neovascularization secondary to pathologic myopia.

This study is planned as a follow-up. Patients with myopia 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.

Patients with a pathologic myopia with CNV (native) will be treated with antiangiogenic drugs according to the regimen pro re nata.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Collaborative Ocular Antiangiogenic Study of Ukraine. Multicentral, Open-label, Randomized, Prospective Study of Antiangiogenic Therapy of Choroidal Neovascularisation Associated With Myopia
• Actual Study Start Date: March 27, 2018
• Estimated Primary Completion Date: July 1, 2020
• Estimated Study Completion Date: December 31, 2020

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Ranibizumab; Arm 1	Procedure: Intravitreal injection; Intravitreal injection to the regimen pro re nata.; Other Name: Patients after general ophthalmic examination (visometry, refractometry, biomicroscopy, ophthalmoscopy, OCT, fluorescence angiography) receive an injection according to the regimen pro re nata.
Active Comparator: Aflibercept; Arm 2	Procedure: Intravitreal injection; Intravitreal injection to the regimen pro re nata.; Other Name: Patients after general ophthalmic examination (visometry, refractometry, biomicroscopy, ophthalmoscopy, OCT, fluorescence angiography) receive an injection according to the regimen pro re nata.

Outcome Measures

Primary Outcome Measures :

1. Mean Change in Best Corrected Visual Acuity (BCVA) as Measured by ETDRS Chart [ Time Frame: Baseline-Month 12 ]
   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 :

1. Mean Change in Central Retinal Thickness (CRT) as Assessed by Optical Coherence Tomography (OCT) [ Time Frame: Baseline-Month 12 ]
   A negative number indicates improvement (reduced thickness).
2. Average Number of Intravitreal Injections [ Time Frame: Baseline-Month 12 ]
   The number of intravitreal injections administered
3. Number of Endophthalmitis after Intravitreal Injections [ Time Frame: Baseline-Month 12 ]
   The number of endophthalmitis registered in patients after intravitreal injections

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 90 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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. Myopia of greater than or equal to -6 D OR axial length of greater than (if the spherical myopic equivalent is <6.0 diopters, then the patient should have myopic changes in the macula: lacquer cracks, focal chorioretinal atrophy, posterior staphyloma) or equal to 26.5 mm.
6. Active subfoveal or juxtafoveal (within 1 to 199 μm of the center of the fovea) CNV secondary to pathologic myopia as defined by leakage on FA.
7. Transparent optical media and possibility to mydriasis.
8. Best corrected visual acuity at least 20/200 Equivalent of Snellen (ETDRS). -

Exclusion Criteria:

1. Ocular media of insufficient quality to obtain fundus and OCT images in the study eye
2. Recurrent mCNV in the study eye
3. History or presence of CNV with an origin other than pathologic myopia 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. History of idiopathic or autoimmune-associated uveitis in either eye
9. Evidence at examination of infectious blepharitis, keratitis, scleritis, or conjunctivitis in either eye or current treatment for serious systemic infection
10. Vitreomacular traction or traction retinal detachment, epiretinal membrane in either eye
11. Any iris neovascularization and/or vitreous hemorrhage in either eye
12. Uncontrolled glaucoma, or previous filtration surgery in either eye
13. Prior and concomitant treatments
14. Any prior or concomitant treatment with another investigational agent for mCNV in the study eye.
15. Any previous panretinal photocoagulation or subfoveal thermal laser therapy in the study eye.

16 Any prior treatment with photodynamic therapy in the study eye. 17. Cataract surgery within 3 months prior to Day 1 in the study eye. 18. Yttrium-aluminum-garnet laser capsulotomy within 2 months prior to Day 1 in the study eye.

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

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

21. Any prior treatment with anti-VEGF agents 22. Previous use of intraocular or periocular corticosteroids in either eye within 3 months prior to Day 1 23. Previous assignment to treatment during this study 24. Uncontrolled hypertension 25. History of cerebrovascular disease or myocardial infarction within 6 months prior to Baseline/Day 1 26. 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 27. 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.

28. Renal failure requiring dialysis or renal transplant 29. 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 30. Known serious allergy to the fluorescein sodium for injection in angiography or Verteporfin 31. Inability to obtain fundus photographs or fluorescein angiograms of sufficient quality

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Contacts and Locations

Contacts

Contact: Andrii MD Korol, PhD; +380936327266; andrii.r.korol@gmail.com

Contact: Viktoriia MD Rostel; +380976126589; rostelviktoria@gmail.com

Locations

Ukraine

Mykolaiv Region Ophthalmogical Hospital; Recruiting

Mykolaiv, Ukraine, 54000

Contact: Krasymira Rylkovа, PhD

Odessa National Medical University; Recruiting

Odessa, Ukraine, 65028

Contact: Nadiia Ulianova, PhD

The Filatov Institute of Eye Diseases and Tissue Therapy; Recruiting

Odessa, Ukraine, 65061

Sponsors and Collaborators

The Filatov Institute of Eye Diseases and Tissue Therapy

Odessa National Medical University

Mykolaiv Region Ophthalmogical Hospital

Central Polyclinic of Internal Affairs of Ukraine

Investigators

• Principal Investigator: Andrii MD Korol, PhD; The Filatov Institute of Eye Diseases and Tissue Therapy

More Information

Publications:

Korol AR, Zadorozhnyy OS, Naumenko VO, Kustryn TB, Pasyechnikova NV. Intravitreal aflibercept for the treatment of choroidal neovascularization associated with pathologic myopia: a pilot study. Clin Ophthalmol. 2016 Nov 4;10:2223-2229. eCollection 2016.

• Responsible Party: Andrii Korol, MD, PhD, Head of Laser Department, The Filatov Institute of Eye Diseases and Tissue Therapy
• ClinicalTrials.gov Identifier: NCT03963596
• Other Study ID Numbers: 0118U001612
• First Posted: May 24, 2019
• Last Update Posted: April 27, 2020
• Last Verified: April 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Keywords provided by Andrii Korol, MD, PhD, The Filatov Institute of Eye Diseases and Tissue Therapy:

fundus diseases; antiangiogenic therapy; choroidal neovascularization; pathologyc myopia; intravitreal injection; anti-VEGF

Additional relevant MeSH terms:

Myopia; Choroidal Neovascularization; Neovascularization, Pathologic; Refractive Errors; Eye Diseases; Metaplasia; Pathologic Processes; Choroid Diseases; Uveal Diseases