Brolucizumab for CNV Associated With Pathologic Myopia (COASTUAbaCNV)

Collaborative Ocular Antiangiogenic Study of Ukraine. Multicentral, Open-label, Randomized, Prospective Study of Antiangiogenic Therapy of Choroidal Neovascularisation Associated With Pathologic Myopia

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

Study Overview

• Status: Recruiting
• Conditions: Pathologic Myopia
• Intervention / Treatment: Procedure: Intravitreal injection

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 randomized, multicenter, open-label, comperative, interventional. Patients with myopia included in it will receive brolucizumab or aflibercept.

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 Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Olha MD Pohosian; Phone Number: +380932084927; Email: olha.a.pohosian@gmail.com

Study Locations

• Ukraine
  • Lutsk, Ukraine, 43025
    • Recruiting
    • Lesya Ukrainka Volyn National University
    • Contact: Nadiia MD Ulianova, PhD
  • Mykolaiv, Ukraine, 54000
    • Recruiting
    • Mykolaiv Region Ophthalmogical Hospital
    • Contact: Krasymira MD Rylkovа, PhD
  • Odesa, Ukraine, 65028
    • Recruiting
    • Odessa National Medical University
    • Contact: Nadiia MD Ulianova, PhD
  • Odesa, Ukraine, 65061
    • Recruiting
    • The Filatov Institute of Eye Diseases and Tissue Therapy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.
• 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.
• 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.
• Transparent optical media and possibility to mydriasis.
• Best corrected visual acuity at least 20/200 Equivalent of Snellen (ETDRS).

Exclusion Criteria:

• Ocular media of insufficient quality to obtain fundus and OCT images in the study eye
• Recurrent mCNV in the study eye
• History or presence of CNV with an origin other than pathologic myopia in the study eye
• Ocular inflammation or external ocular inflammation in the study eye
• 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
• History of idiopathic or autoimmune-associated uveitis in either 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
• Uncontrolled glaucoma, or previous filtration surgery in either eye
• Prior and concomitant treatments
• Any prior or concomitant treatment with another investigational agent for mCNV 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.
• Cataract surgery within 3 months prior to Day 1 in the study eye.
• 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
• Previous use of intraocular or periocular corticosteroids in either eye within 3 months prior to Day 1
• Previous assignment to treatment during this study
• Uncontrolled hypertension
• History of cerebrovascular disease or myocardial infarction within 6 months prior to Baseline/Day 1
• 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
• 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.
• Renal failure requiring dialysis or renal transplant
• 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
• Known serious allergy to the fluorescein sodium for injection in angiography or Verteporfin
• Inability to obtain fundus photographs or fluorescein angiograms of sufficient quality

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Brolucizumab; Arm B	Procedure: Intravitreal injection; Intravitreal injection to the regimen pro re nata; Other Names: Patients after general ophthalmic examination (visometry, refractometry, biomicroscopy, ophthalmoscopy, OCT, FA) receive injections according to the regimen pro re nata from the initial injection.
Active Comparator: Aflibercept; Arm A	Procedure: Intravitreal injection; Intravitreal injection to the regimen pro re nata; Other Names: Patients after general ophthalmic examination (visometry, refractometry, biomicroscopy, ophthalmoscopy, OCT, FA) receive injections according to the regimen pro re nata from the initial injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change in Central Retinal Thickness (CRT) as Assessed by Optical Coherence Tomography (OCT)	A negative number indicates improvement (reduced thickness).	Baseline-Month 12
Average Number of Intravitreal Injections	The number of intravitreal injections administered	Baseline-Month 12
Number of Inflamations after Intravitreal Injections	The number of inflamations registered in patients after intravitreal injections	Baseline-Month 12

Collaborators and Investigators

• 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; Lesya Ukrainka Volyn National University

Publications and helpful links

General 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. doi: 10.2147/OPTH.S117791. eCollection 2016.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2021
• Primary Completion (Anticipated): April 1, 2022
• Study Completion (Anticipated): April 1, 2022

Study Registration Dates

• First Submitted: July 19, 2021
• First Submitted That Met QC Criteria: July 19, 2021
• First Posted (Actual): July 26, 2021

Study Record Updates

• Last Update Posted (Actual): March 24, 2022
• Last Update Submitted That Met QC Criteria: March 23, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: intravitreal injection; anti-VEGF; choroidal neovascularization; aflibercept; brolucizumab; antiangiogenic therapy; fundus diseases; pathologyc myopia
• Additional Relevant MeSH Terms: Pathologic Processes; Eye Diseases; Uveal Diseases; Choroid Diseases; Refractive Errors; Metaplasia; Neovascularization, Pathologic; Choroidal Neovascularization; Myopia
• Other Study ID Numbers: 0118U001612m

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No