CompletedNot Applicable

Antiangiogenic Therapy of Choroidal Neovascularisation Associated With Myopia

Ukraine122 participantsStarted 2018-03-27

Plain-language summary

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

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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). -

✕. 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

Mean Change in Best Corrected Visual Acuity (BCVA) as Measured by ETDRS Chart

Timeframe: Baseline-Month 12

NCT IDNCT03963596

SponsorThe Filatov Institute of Eye Diseases and Tissue Therapy

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-07-01

Who can participate

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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). -

✕. 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