Antiangiogenic Therapy of Choroidal Neovascularisation Associated With Central Chorioretinitis

  • STATUS
    Recruiting
  • End date
    Jan 31, 2022
  • participants needed
    100
  • sponsor
    The Filatov Institute of Eye Diseases and Tissue Therapy
Updated on 16 February 2021

Summary

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

Description

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

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

Details
Condition Chorioretinitis
Treatment intravitreal injection, Slit lamp examination, Fluorescent angiography, Visometry, Refractometry, Refractometry, Ophthalmoscopy, Ophthalmoscopy, OKT
Clinical Study IdentifierNCT04245072
SponsorThe Filatov Institute of Eye Diseases and Tissue Therapy
Last Modified on16 February 2021

Eligibility

Yes No Not Sure

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 m 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)

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 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
Maular 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
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
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