Pathologic MyopiaCOASTUAbaCNVNCT04976244
Brolucizumab for CNV Associated With Pathologic Myopia
A study testing Intravitreal injection in people with Pathologic Myopia, run by The Filatov Institute of Eye Diseases and Tissue Therapy at 4 sites in Ukraine.
Trial summary
The purpose of this study is to determine the effectiveness of antiangiogenic therapy to choroidal neovascularization secondary to pathologic myopia. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pathologic Myopia
- What is being tested?
- Intravitreal injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 4 sitesUkraine
- Study dates
- 1 Apr 2021to 1 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Show all 31Show fewer
- 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.
- 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
Trial locations and contacts
4 sites in 1 country.
Ukraine4 sites, 4 recruiting
- Recruiting
Lesya Ukrainka Volyn National University
Lutsk, 43025
Nadiia MD Ulianova, PhD
- Recruiting
Mykolaiv Region Ophthalmogical Hospital
Mykolaiv, 54000
Krasymira MD Rylkovа, PhD
- Recruiting
Odessa National Medical University
Odesa, 65028
Nadiia MD Ulianova, PhD
- Recruiting
The Filatov Institute of Eye Diseases and Tissue Therapy
Odesa, 65061
About this study
Official title: Collaborative Ocular Antiangiogenic Study of Ukraine. Multicentral, Open-label, Randomized, Prospective Study of Antiangiogenic Therapy of Choroidal Neovascularisation Associated With Pathologic Myopia
The purpose of this study is to determine the effectiveness of antiangiogenic therapy to choroidal neovascularization secondary to pathologic myopia.
Read the detailed description
The purpose of this study is to determine the effectiveness of antiangiogenic therapy to choroidal neovascularization secondary to pathologic myopia.
This study is planned as a randomized, multicenter, open-label, comperative, interventional. Patients with myopia included in it will receive brolucizumab or aflibercept.
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.
Patients with a pathologic myopia with CNV (native) will be treated with antiangiogenic drugs according to the regimen pro re nata.
- Conditions
- Pathologic Myopia
- Being tested
- Intravitreal injection
- Keywords
- fundus diseases, antiangiogenic therapy, choroidal neovascularization, pathologyc myopia, intravitreal injection, anti-VEGF, brolucizumab, aflibercept
- Medical subject headings
- Choroidal Neovascularization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravitreal injectionProcedure or surgery
Also called Patients after general ophthalmic examination (visometry, refractometry, biomicroscopy, ophthalmoscopy, OCT, FA) receive injections according to the regimen pro re nata from the initial injection.
Intravitreal injection to the regimen pro re nata
| Study group | Role | What they receive |
|---|---|---|
| Brolucizumab | Active comparator | Arm B Receives: Procedure: Intravitreal injection |
| Aflibercept | Active comparator | Arm A Receives: Procedure: Intravitreal injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline-Month 12
Secondary outcomes (3)
Mean Change in Central Retinal Thickness (CRT) as Assessed by Optical Coherence Tomography (OCT)
A negative number indicates improvement (reduced thickness).
Measured: Baseline-Month 12
Average Number of Intravitreal Injections
The number of intravitreal injections administered
Measured: Baseline-Month 12
Number of Inflamations after Intravitreal Injections
The number of inflamations registered in patients after intravitreal injections
Measured: Baseline-Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2021
- Study start1 Apr 2021
- Primary completion1 Apr 2022 (estimated)
- Study completion1 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pathologic MyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Filatov Institute of Eye Diseases and Tissue Therapy
- Sponsor type
- University, hospital or other
- Collaborators
- Odessa National Medical University, Mykolaiv Region Ophthalmogical Hospital, Central Polyclinic of Internal Affairs of Ukraine, Lesya Ukrainka Volyn National University
- Responsible party
- Principal investigator, Andrii Korol, MD, PhD, The Filatov Institute of Eye Diseases and Tissue Therapy
- Investigators
- Andrii MD Korol, PhD, Principal investigator, The Filatov Institute of Eye Diseases and Tissue Therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04976244
- Sponsor's protocol ID
- 0118U001612m
- Acronym
- COASTUAbaCNV
- Status last verified
- Mar 2022
- First submitted
- 19 Jul 2021
- Last updated
- 24 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27853350
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collaborative Ocular Antiangiogenic Study of Ukraine. Multicentral, Open-label, Randomized, Prospective Study of Antiangiogenic Therapy of Choroidal Neovascularisation Associated With Pathologic Myopia
- ClinicalTrials.gov ID
- NCT04976244
- Acronym / sponsor ID
- COASTUAbaCNV / 0118U001612m
- Conditions
- Pathologic Myopia
- Keywords
- fundus diseases, antiangiogenic therapy, choroidal neovascularization, pathologyc myopia, intravitreal injection, anti-VEGF, brolucizumab, aflibercept
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- The Filatov Institute of Eye Diseases and Tissue TherapyUniversity, hospital or other
- Collaborators
- Odessa National Medical University, Mykolaiv Region Ophthalmogical Hospital, Central Polyclinic of Internal Affairs of Ukraine, Lesya Ukrainka Volyn National University
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 1 Apr 2022 (estimated)
- Study completion
- 1 Apr 2022 (estimated)
- First posted
- 26 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the effectiveness of antiangiogenic therapy to choroidal neovascularization secondary to pathologic myopia.
Detailed description
The purpose of this study is to determine the effectiveness of antiangiogenic therapy to choroidal neovascularization secondary to pathologic myopia.
This study is planned as a randomized, multicenter, open-label, comperative, interventional. Patients with myopia included in it will receive brolucizumab or aflibercept.
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.
Patients with a pathologic myopia with CNV (native) will be treated with antiangiogenic drugs according to the regimen pro re nata.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brolucizumab | Active comparator | Procedure: Intravitreal injectionArm B |
| Aflibercept | Active comparator | Procedure: Intravitreal injectionArm A |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (31 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intravitreal injectionAlso: Patients after general ophthalmic examination (visometry, refractometry, biomicroscopy, ophthalmoscopy, OCT, FA) receive injections according to the regimen pro re nata from the initial injection.Intravitreal injection to the regimen pro re nata | Procedure or surgery | Aflibercept, Brolucizumab |
Primary outcome
Mean Change in Best Corrected Visual Acuity (BCVA) as Measured by ETDRS Chart
Time frame: Baseline-Month 12
Defined study baseline range of ETDRS equivalent of 20/200 to 20/20) in the study eye; a higher score represents better functioning.
3 secondary outcomes
Mean Change in Central Retinal Thickness (CRT) as Assessed by Optical Coherence Tomography (OCT)
Time frame: Baseline-Month 12
Average Number of Intravitreal Injections
Time frame: Baseline-Month 12
Number of Inflamations after Intravitreal Injections
Time frame: Baseline-Month 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2022.
- Background: PubMed 27853350Korol 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrii MD Korol, PhD principal investigator
The Filatov Institute of Eye Diseases and Tissue Therapy
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intravitreal injection in people with Pathologic Myopia, run by The Filatov Institute of Eye Diseases and Tissue Therapy at 4 sites in Ukraine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Ukraine. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrii MD Korol, PhD (+380936327266, andrii.r.korol@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Change in Best Corrected Visual Acuity (BCVA) as Measured by ETDRS Chart (time frame: Baseline-Month 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04976244, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2022.