Antiangiogenic Therapy of Choroidal Neovascularisation Associated With Myopia

NCT03963596 | Completed

• 1 other identifier: 0118U001612
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Pathologic Myopia

Keywords

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

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 COMPARATOR

Arm 1

Procedure: Intravitreal injection

Aflibercept

ACTIVE COMPARATOR

Arm 2

Procedure: Intravitreal injection

Interventions

Intravitreal injection PROCEDURE

Intravitreal injection to the regimen pro re nata.

Also known as: Patients after general ophthalmic examination (visometry, refractometry, biomicroscopy, ophthalmoscopy, OCT, fluorescence angiography) receive an injection according to the regimen pro re nata.

Aflibercept; Ranibizumab

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.
• 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). -

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Filatov Institute of Eye Diseases and Tissue Therapy: lead
• Odessa National Medical University: collaborator
• Mykolaiv Region Ophthalmogical Hospital: collaborator
• Central Polyclinic of Internal Affairs of Ukraine: collaborator

Study Sites (3)

Mykolaiv Region Ophthalmogical Hospital

Mykolaiv, 54000, Ukraine

Location

Odessa National Medical University

Odesa, 65028, Ukraine

Location

The Filatov Institute of Eye Diseases and Tissue Therapy

Odesa, 65061, Ukraine

Location

Related Publications (1)

• 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.

  PMID: 27853350 BACKGROUND

MeSH Terms

Conditions

Choroidal Neovascularization

Interventions

Intravitreal Injections; Refractometry

Condition Hierarchy (Ancestors)

Choroid Diseases; Uveal Diseases; Eye Diseases; Neovascularization, Pathologic; Metaplasia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Injections, Intraocular; Injections; Drug Administration Routes; Drug Therapy; Therapeutics; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Andrii MD Korol, PhD

  The Filatov Institute of Eye Diseases and Tissue Therapy

  PRINCIPAL INVESTIGATOR

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: May 21, 2019
• First Posted: May 24, 2019
• Study Start: March 27, 2018
• Primary Completion: July 1, 2020
• Study Completion: December 31, 2020
• Last Updated: January 25, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

UA (3)