NCT04245072

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 27, 2018

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

November 29, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 28, 2020

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2022

Completed
Last Updated

February 3, 2021

Status Verified

February 1, 2021

Enrollment Period

3.8 years

First QC Date

November 29, 2019

Last Update Submit

February 2, 2021

Conditions

Chorioretinitis

Keywords

fundus diseasesantiangiogenic therapychoroidal neovascularizationintravitreal injectionanti-VEGFcentral chorioretinitis

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 injectionDiagnostic Test: Fluorescent angiographyDiagnostic Test: VisometryDiagnostic Test: RefractometryDiagnostic Test: Slit lamp examinationDiagnostic Test: OphthalmoscopyDiagnostic Test: OKT

Aflibercept

ACTIVE COMPARATOR

Arm 2

Procedure: Intravitreal injectionDiagnostic Test: Fluorescent angiographyDiagnostic Test: VisometryDiagnostic Test: RefractometryDiagnostic Test: Slit lamp examinationDiagnostic Test: OphthalmoscopyDiagnostic Test: OKT

Interventions

Intravitreal injectionPROCEDURE

Intravitreal injection of Aflibercept 2 mg (0.05 ml) or Ranibizumab 0.5 mg (0.05 ml) to the regimen pro re nata.

Also known as: Patients after general ophthalmic examination receive an injection according to the regimen pro re nata.
AfliberceptRanibizumab
Fluorescent angiographyDIAGNOSTIC_TEST

Ophthalmic examination

AfliberceptRanibizumab
VisometryDIAGNOSTIC_TEST

Ophthalmic examination

AfliberceptRanibizumab
RefractometryDIAGNOSTIC_TEST

Ophthalmic examination

AfliberceptRanibizumab
Slit lamp examinationDIAGNOSTIC_TEST

Ophthalmic examination

AfliberceptRanibizumab
OphthalmoscopyDIAGNOSTIC_TEST

Ophthalmic examination

AfliberceptRanibizumab
OKTDIAGNOSTIC_TEST

Ophthalmic examination

AfliberceptRanibizumab

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (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.
  • First diagnosed active subfoveal or juxtafoveal (within 1 to 199 μm of the center of the fovea) CNV secondary to chorioretinitis 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 chorioretinitis 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
  • 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
  • Maсular hole.
  • 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 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Mykolaiv Region Ophthalmogical Hospital

Mykolaiv, 54000, Ukraine

RECRUITING

Odessa National Medical University

Odesa, 65028, Ukraine

RECRUITING

The Filatov Institute of Eye Diseases and Tissue Therapy

Odesa, 65061, Ukraine

RECRUITING

MeSH Terms

Conditions

ChorioretinitisChoroidal Neovascularization

Interventions

Intravitreal InjectionsFluorescein AngiographySlit Lamp MicroscopyOphthalmoscopy

Condition Hierarchy (Ancestors)

RetinitisRetinal DiseasesEye DiseasesChoroiditisChoroid DiseasesUveal DiseasesUveitis, PosteriorPanuveitisUveitisNeovascularization, PathologicMetaplasiaPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Injections, IntraocularInjectionsDrug Administration RoutesDrug TherapyTherapeuticsAngiographyDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, Ophthalmological

Study Officials

  • Andrii MD Korol, PhD

    The Filatov Institute of Eye Diseases and Tissue Therapy

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrii MD Korol, PhD

CONTACT

+380936327266andrii.r.korol@gmail.com

Viktoriia MD Rostel

CONTACT

+380976126589rostelviktoria@gmail.com

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

November 29, 2019

First Posted

January 28, 2020

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

Locations

UA(3)