Antiangiogenic Therapy of CNV Associated With Angioid Streaks
NCT ID: NCT04119219
Last Updated: 2021-02-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
100 participants
INTERVENTIONAL
2018-03-27
2022-01-31
Brief Summary
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Detailed Description
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This study is planned as a follow-up. Patients with angioid streaks 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Ranibizumab
Arm 1
Intravitreal injection
Intravitreal injection to the regimen pro re nata.
Aflibercept
Arm 2
Intravitreal injection
Intravitreal injection to the regimen pro re nata.
Interventions
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Intravitreal injection
Intravitreal injection to the regimen pro re nata.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Signed informed consent form.
3. Men and women ≥ 18 years of age.
4. Willing, committed, and able to return for all clinic visits and complete all study-related procedures.
5. First diagnosed active subfoveal or juxtafoveal (within 1 to 199 μm of the center of the fovea) CNV secondary to angioid streaks as defined by leakage on FA
6. Transparent optical media and possibility to mydriasis.
7. Best corrected visual acuity at least 20/100 Equivalent of Snellen (ETDRS).
Exclusion Criteria
2. Recurrent CNV in the study eye.
3. History or presence of CNV with an origin other than angioid streaks in the study eye.
4. Ocular inflammation or external ocular inflammation in the study eye. 5 Concurrent disease in the study eye that would compromise BCVA or require medical or surgical intervention during the study period.
6\. Any ocular disorder in the study eye that, in the opinion of the investigator, may confound interpretation of the study results.
7\. Significant scarring or atrophy in the fovea that indicates substantial irreversible vision loss in the study eye.
8\. Evidence at examination of infectious blepharitis, keratitis, scleritis, or conjunctivitis in either eye or current treatment for serious systemic infection.
9\. Vitreomacular traction or traction retinal detachment, epiretinal membrane in either eye.
10\. Any iris neovascularization and/or vitreous hemorrhage in either eye. 11. Uncontrolled glaucoma, or previous filtration surgery in either eye. 12. Any prior or concomitant treatment with another investigational agent for CNV in the study eye.
13\. Any previous panretinal photocoagulation or subfoveal thermal laser therapy in the study eye.
14\. Any prior treatment with photodynamic therapy in the study eye. 15. Cataract surgery within 3 months prior to Day 1 in the study eye. 16. Yttrium-aluminum-garnet laser capsulotomy within 2 months prior to Day 1 in the study eye.
17\. Any other intraocular surgery within 3 months prior to Day 1 in the study eye.
18\. History of vitreoretinal surgery and/or scleral buckle surgery in the study eye.
19\. Any prior treatment with anti-VEGF agents. 20. Previous use of intraocular or periocular corticosteroids in either eye within 3 months prior to Day 1.
21\. Previous assignment to treatment during this study. 22. Uncontrolled hypertension. 23. History of cerebrovascular disease or myocardial infarction within 6 months prior to Baseline/Day 1.
24\. 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.
25\. 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.
26\. Renal failure requiring dialysis or renal transplant. 27. 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.
28\. Known serious allergy to the fluorescein sodium for injection in angiography or Verteporfin.
29\. Inability to obtain fundus photographs or fluorescein angiograms of sufficient quality
18 Years
90 Years
ALL
No
Sponsors
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Odessa National Medical University
OTHER
Mykolaiv Region Ophthalmogical Hospital
OTHER
Central Polyclinic of Internal Affairs of Ukraine
OTHER_GOV
The Filatov Institute of Eye Diseases and Tissue Therapy
OTHER
Responsible Party
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Andrii Korol, MD, PhD
Head of Laser Department
Principal Investigators
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Andrii MD Korol, PhD
Role: PRINCIPAL_INVESTIGATOR
The Filatov Institute of Eye Diseases and Tissue Therapy
Locations
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Mykolaiv Region Ophthalmogical Hospital
Mykolaiv, , Ukraine
Odessa National Medical University
Odesa, , Ukraine
The Filatov Institute of Eye Diseases and Tissue Therapy
Odesa, , Ukraine
Countries
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Central Contacts
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Facility Contacts
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Krasymira Rylkovа, PhD
Role: primary
Nadiia Ulianova, PhD
Role: primary
Other Identifiers
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0118U001612/3
Identifier Type: -
Identifier Source: org_study_id
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