Myopia, PathologicalPhase 3MyrrorNCT01249664
VEGF Trap-Eye in Choroidal Neovascularization Secondary to Pathologic Myopia (mCNV)
A Phase 3 study testing VEGF Trap-Eye (BAY86-5321) and No Drug in people with Myopia, Pathological, run by Bayer at 20 sites in 5 countries.
Trial summary
VEGF Trap-Eye will be tested for safety and efficacy in patients with vision loss due to choroidal neovascularization secondary to pathologic myopia. This will be a placebo-controlled trial. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myopia, Pathological
- What is being tested?
- VEGF Trap-Eye (BAY86-5321) and No Drug
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 122 participants
- Where
- 20 sitesin 5 countries
- Study dates
- Dec 2010to Aug 2013
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- 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. In Japan only, the informed consent form for a subject under the age of 20 years will require the co-signature of the subject's legally authorized representative.
- Men and women ≥ 18 years of age
- Myopia of greater than or equal to -6 D OR axial length of greater than 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
- Best-corrected visual acuity of 73 to 35 letters (ETDRS equivalent of 20/40 to 20/200) in the study eye at 4 meters
- Decrease in vision in the study eye is determined by the investigator, using his/her medical judgment, to be primarily the result of the current active mCNV
- Willing, committed, and able to return for all clinic visits and complete all study-related procedures
Who cannot join
- Only one functional eye
- Ocular media of insufficient quality to obtain fundus and OCT images in the study eye
- Greatest linear dimension (GLD) of the lesion in the study eye is greater than 12 disc areas
- Recurrent mCNV in the study eye
- Aphakia in the study eye
- History or presence of CNV with an origin other than pathologic myopia in the study eye
Show all 35Show fewer
- 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
- 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
- In the study eye:
- Any prior or concomitant treatment with another investigational agent for mCNV
- Any previous panretinal photocoagulation or subfoveal thermal laser therapy
- Any prior treatment with photodynamic therapy
- Cataract surgery within 3 months prior to Day 1
- Yttrium-aluminum-garnet laser capsulotomy within 2 months prior to Day 1
- Any other intraocular surgery within 3 months prior to Day 1
- History of vitreoretinal surgery and/or scleral buckle surgery
- 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
20 sites in 5 countries.
20 sites in 5 countries
Japan15 sites
Study site
Bunkyo-ku, Tokyo, 113-8519
Study site
Chiyoda-ku, Tokyo, 101-8309
Study site
Fukuoka, Fukuoka, 812-8582
Study site
Fukushima, Fukushima, 960-1295
Study site
Kyoto, Kyoto, 606-8507
Study site
Matsuyama, Ehime, 790-8524
Study site
Nagoya, Aichi-ken, 466-8560
Study site
Nagoya, Aichi-ken, 467-8602
Study site
Osaka, Osaka, 545-8586
Study site
Osaka, Osaka, 558-8558
Study site
Ōtsu, Shiga, 520-2192
Study site
Sendai, Miyagi, 984-8560
Study site
Shinjuku-ku, Tokyo, 160-8582
Study site
Suita, Osaka, 565-0871
Study site
Urayasu, Chiba, 279-0021
About this study
Official title: A Phase-3, Multi-center, Randomized, Double-masked, Sham-controlled Study of the Efficacy, Safety, and Tolerability of Intravitreal VEGF Trap-Eye in Subjects With Choroidal Neovascularization Secondary to Pathologic Myopia
VEGF Trap-Eye will be tested for safety and efficacy in patients with vision loss due to choroidal neovascularization secondary to pathologic myopia. This will be a placebo-controlled trial. 3 out of 4 patients will receive an injection of VEGF Trap-Eye into the affected eye (and repeated injections if required), and 1 out of 4 patients will receive a sham injection requiring no needle stick, but making the patient unaware of whether or not he received active treatment.
Outcome of the two treatment groups will be compared after 24 weeks. From week 24, sham patients may receive active treatment.
Total duration of the study will be 48 weeks.
- Conditions
- Myopia, Pathological
- Being tested
- VEGF Trap-Eye (BAY86-5321), No Drug
- Keywords
- sham-controlled, pathologic myopia, mCNV, choroidal neovascularization, intravitreal injection, vision loss, macular damage
- Medical subject headings
- Myopia, Degenerative, Choroidal Neovascularization, Vision Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VEGF Trap-Eye (BAY86-5321)Biological
1 intravitreal injection of the experimental drug, followed by monthly re-injections if needed
No DrugProcedure or surgery
Sham procedure NOT involving injection of any substance; patient´s eye is anesthetized and a syringe without needle gently pressed on the cornea
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Biological: VEGF Trap-Eye (BAY86-5321) |
| Arm 2 | Sham comparator | Not described Receives: Procedure: No Drug |
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 Early Treatment Diabetic Retinopathy Study (ETDRS) From Baseline to Week 24 - Last Observation Carried Forward (LOCF)
Defined study baseline range of ETDRS Best Corrected Visual Acuity letter score of 73 to 35 letters (ETDRS equivalent of 20/40 to 20/200) in the study eye; a higher score represents better functioning.
Measured: Baseline, Week 24
Secondary outcomes (21)
Percentage of Participants Who Gained at Least 15 Letters in BCVA as Measured by ETDRS at Week 24 Using the LOCF Approach
Defined study baseline range of Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score of 73 to 35 letters (ETDRS equivalent of 20/40 to 20/200) in the study eye; a higher score represents better functioning. Nominator = (Number of participants who maintained vision * 100); Denominator = Number of participants analyzed.
Measured: Baseline, Week 24
Mean Change in Best Corrected Visual Acuity (BCVA) as Measured by ETDRS From Baseline to Week 24 - Observed Cases
Data as observed at visit, no carrying forward from latest observation if missing data at later time points. Defined study baseline range of ETDRS Best Corrected Visual Acuity letter score of 73 to 35 letters (ETDRS equivalent of 20/40 to 20/200) in the study eye; a higher score represents better functioning.
Measured: Baseline, Week 24
Percentage of Participants Who Gained at Least 10 Letters in BCVA at Week 24 - LOCF
Defined study baseline range of Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score of 73 to 35 letters (ETDRS equivalent of 20/40 to 20/200) in the study eye; a higher score represents better functioning. Nominator = (Number of participants who maintained vision * 100); Denominator = Number of participants analyzed.
Measured: Baseline, Week 24
Percentage of Participants Who Gained at Least 5 Letters in BCVA at Week 24 - LOCF
Defined study baseline range of Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score of 73 to 35 letters (ETDRS equivalent of 20/40 to 20/200) in the study eye; a higher score represents better functioning. Nominator = (Number of participants who maintained vision * 100); Denominator = Number of participants analyzed.
Measured: Baseline, Week 24
Percentage of Participants Who Gained at Least 15 Letters in BCVA at Week 48 - LOCF
Defined study baseline range of Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score of 73 to 35 letters (ETDRS equivalent of 20/40 to 20/200) in the study eye; a higher score represents better functioning. Nominator = (Number of participants who maintained vision * 100); Denominator = Number of participants analyzed.
Measured: Baseline, Week 48
Percentage of Participants Who Gained at Least 10 Letters in BCVA at Week 48 - LOCF
Defined study baseline range of Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score of 73 to 35 letters (ETDRS equivalent of 20/40 to 20/200) in the study eye; a higher score represents better functioning. Nominator = (Number of participants who maintained vision * 100); Denominator = Number of participants analyzed.
Measured: Baseline, Week 48
Percentage of Participants Who Gained at Least 5 Letters in BCVA at Week 48 - LOCF
Defined study baseline range of Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score of 73 to 35 letters (ETDRS equivalent of 20/40 to 20/200) in the study eye; a higher score represents better functioning. Nominator = (Number of participants who maintained vision * 100); Denominator = Number of participants analyzed.
Measured: Baseline, Week 48
Percentage of Participants Who Lost at Least 15 Letters in BCVA at Week 24 - LOCF
Defined study baseline range of Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score of 73 to 35 letters (ETDRS equivalent of 20/40 to 20/200) in the study eye; a higher score represents better functioning. Nominator = (Number of participants who maintained vision * 100); Denominator = Number of participants analyzed.
Measured: Baseline, Week 24
Percentage of Participants Who Lost at Least 10 Letters in BCVA at Week 24 - LOCF
Defined study baseline range of Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score of 73 to 35 letters (ETDRS equivalent of 20/40 to 20/200) in the study eye; a higher score represents better functioning. Nominator = (Number of participants who maintained vision * 100); Denominator = Number of participants analyzed.
Measured: Baseline, Week 24
Percentage of Participants Who Lost at Least 5 Letters in BCVA at Week 24 - LOCF
Defined study baseline range of Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score of 73 to 35 letters (ETDRS equivalent of 20/40 to 20/200) in the study eye; a higher score represents better functioning. Nominator = (Number of participants who maintained vision * 100); Denominator = Number of participants analyzed.
Measured: Baseline, Week 24
Percentage of Participants Who Lost at Least 15 Letters in BCVA at Week 48 - LOCF
Defined study baseline range of Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score of 73 to 35 letters (ETDRS equivalent of 20/40 to 20/200) in the study eye; a higher score represents better functioning. Nominator = (Number of participants who maintained vision * 100); Denominator = Number of participants analyzed.
Measured: Baseline, Week 48
Percentage of Participants Who Lost at Least 10 Letters in BCVA at Week 48 - LOCF
Defined study baseline range of Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score of 73 to 35 letters (ETDRS equivalent of 20/40 to 20/200) in the study eye; a higher score represents better functioning. Nominator = (Number of participants who maintained vision * 100); Denominator = Number of participants analyzed.
Measured: Baseline, Week 48
Percentage of Participants Who Lost at Least 5 Letters in BCVA at Week 48 - LOCF
Defined study baseline range of Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score of 73 to 35 letters (ETDRS equivalent of 20/40 to 20/200) in the study eye; a higher score represents better functioning. Nominator = (Number of participants who maintained vision * 100); Denominator = Number of participants analyzed.
Measured: Baseline, Week 48
Mean Change in Central Retinal Thickness (CRT) as Assessed by Optical Coherence Tomography (OCT) From Baseline to Week 24 - LOCF
A negative number indicates improvement (reduced thickness).
Measured: Baseline, Week 24
Mean Change in Central Retinal Thickness (CRT) as Assessed by Optical Coherence Tomography (OCT) From Baseline to Week 48 - LOCF
A negative number indicates improvement (reduced thickness).
Measured: Baseline, Week 48
Mean Change in Choroidal Neovascularization (CNV) Lesion Size as Assessed by Fluorescein Angiography (FA) From Baseline to Week 24 - LOCF
CNV area values measured in square millimeters, each disc area is equivalent to 2.54 mm^2 on the retina; lower values represent better outcomes
Measured: Baseline, Week 24
Mean Change in Choroidal Neovascularization (CNV) Lesion Size as Assessed by Fluorescein Angiography (FA) From Baseline to Week 48 - LOCF
CNV area values measured in square millimeters, each disc area is equivalent to 2.54 mm^2 on the retina; lower values represent better outcomes
Measured: Baseline, Week 48
Mean Change in European Five-dimensional Health Scale (EQ-5D) Score From Baseline to Week 24 - LOCF
EQ-5D is a quality of life questionnaire based on a scale from -0.594 (worst) to 1.00 (best).
Measured: Baseline, Week 24
Mean Change in National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) Total Score From Baseline to Week 24 - LOCF
The NEI VFQ-25 total score ranges from 0-100 with a score of 0 being the worst outcome and 100 being the best outcome. The NEI VFQ questionnaire is organized as a collection of subscales which are all scored from 0-100. To reach the overall composite score, each sub-scale score is averaged in order to give each sub-scale equal weight.
Measured: Baseline, Week 24
Percentage of Participants Who Were Withdrawn From Study Drug During the First 24 Weeks
Measured: Baseline, Week 24
Mean Change in Area of Leakage From Baseline at Week 24 - LOCF
A negative change from baseline indicates improvement, ie, less leakage.
Measured: Baseline, Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2010 (estimated)
- Study startDec 2010
- Primary completionFeb 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Myopia, PathologicalStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Regeneron Pharmaceuticals
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01249664
- Sponsor's protocol ID
- 15170
- Acronym
- Myrror
- Status last verified
- Apr 2014
- First submitted
- 26 Nov 2010
- Last updated
- 5 May 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase-3, Multi-center, Randomized, Double-masked, Sham-controlled Study of the Efficacy, Safety, and Tolerability of Intravitreal VEGF Trap-Eye in Subjects With Choroidal Neovascularization Secondary to Pathologic Myopia
- ClinicalTrials.gov ID
- NCT01249664
- Acronym / sponsor ID
- Myrror / 15170
- Conditions
- Myopia, Pathological
- Keywords
- sham-controlled, pathologic myopia, mCNV, choroidal neovascularization, intravitreal injection, vision loss, macular damage
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Collaborators
- Regeneron Pharmaceuticals
- Study start
- Dec 2010
- Primary completion
- Feb 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 30 Nov 2010 (estimated)
- Results
- Posted 1 Apr 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
VEGF Trap-Eye will be tested for safety and efficacy in patients with vision loss due to choroidal neovascularization secondary to pathologic myopia. This will be a placebo-controlled trial. 3 out of 4 patients will receive an injection of VEGF Trap-Eye into the affected eye (and repeated injections if required), and 1 out of 4 patients will receive a sham injection requiring no needle stick, but making the patient unaware of whether or not he received active treatment.
Outcome of the two treatment groups will be compared after 24 weeks. From week 24, sham patients may receive active treatment.
Total duration of the study will be 48 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Biological: VEGF Trap-Eye (BAY86-5321) |
| Arm 2 | Sham comparator | Procedure: No Drug |
Who may qualify
- Ages
- 18 years and older
- 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. In Japan only, the informed consent form for a subject under the age of 20 years will require the co-signature of the subject's legally authorized representative.
- Men and women ≥ 18 years of age
- Myopia of greater than or equal to -6 D OR axial length of greater than 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
Key exclusion criteria (35 listed)
- Only one functional eye
- Ocular media of insufficient quality to obtain fundus and OCT images in the study eye
- Greatest linear dimension (GLD) of the lesion in the study eye is greater than 12 disc areas
- Recurrent mCNV in the study eye
- Aphakia in the study eye
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 |
|---|---|---|
| VEGF Trap-Eye (BAY86-5321)1 intravitreal injection of the experimental drug, followed by monthly re-injections if needed | Biological | Arm 1 |
| No DrugSham procedure NOT involving injection of any substance; patient´s eye is anesthetized and a syringe without needle gently pressed on the cornea | Procedure or surgery | Arm 2 |
Primary outcome
Mean Change in Best Corrected Visual Acuity (BCVA) as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) From Baseline to Week 24 - Last Observation Carried Forward (LOCF)
Time frame: Baseline, Week 24
Defined study baseline range of ETDRS Best Corrected Visual Acuity letter score of 73 to 35 letters (ETDRS equivalent of 20/40 to 20/200) in the study eye; a higher score represents better functioning.
21 secondary outcomes
Percentage of Participants Who Gained at Least 15 Letters in BCVA as Measured by ETDRS at Week 24 Using the LOCF Approach
Time frame: Baseline, Week 24
Mean Change in Best Corrected Visual Acuity (BCVA) as Measured by ETDRS From Baseline to Week 24 - Observed Cases
Time frame: Baseline, Week 24
Percentage of Participants Who Gained at Least 10 Letters in BCVA at Week 24 - LOCF
Time frame: Baseline, Week 24
Percentage of Participants Who Gained at Least 5 Letters in BCVA at Week 24 - LOCF
Time frame: Baseline, Week 24
Percentage of Participants Who Gained at Least 15 Letters in BCVA at Week 48 - LOCF
Time frame: Baseline, Week 48
Percentage of Participants Who Gained at Least 10 Letters in BCVA at Week 48 - LOCF
Time frame: Baseline, Week 48
Percentage of Participants Who Gained at Least 5 Letters in BCVA at Week 48 - LOCF
Time frame: Baseline, Week 48
Percentage of Participants Who Lost at Least 15 Letters in BCVA at Week 24 - LOCF
Time frame: Baseline, Week 24
Percentage of Participants Who Lost at Least 10 Letters in BCVA at Week 24 - LOCF
Time frame: Baseline, Week 24
Percentage of Participants Who Lost at Least 5 Letters in BCVA at Week 24 - LOCF
Time frame: Baseline, Week 24
Percentage of Participants Who Lost at Least 15 Letters in BCVA at Week 48 - LOCF
Time frame: Baseline, Week 48
Percentage of Participants Who Lost at Least 10 Letters in BCVA at Week 48 - LOCF
Time frame: Baseline, Week 48
Percentage of Participants Who Lost at Least 5 Letters in BCVA at Week 48 - LOCF
Time frame: Baseline, Week 48
Mean Change in Central Retinal Thickness (CRT) as Assessed by Optical Coherence Tomography (OCT) From Baseline to Week 24 - LOCF
Time frame: Baseline, Week 24
Mean Change in Central Retinal Thickness (CRT) as Assessed by Optical Coherence Tomography (OCT) From Baseline to Week 48 - LOCF
Time frame: Baseline, Week 48
Mean Change in Choroidal Neovascularization (CNV) Lesion Size as Assessed by Fluorescein Angiography (FA) From Baseline to Week 24 - LOCF
Time frame: Baseline, Week 24
Mean Change in Choroidal Neovascularization (CNV) Lesion Size as Assessed by Fluorescein Angiography (FA) From Baseline to Week 48 - LOCF
Time frame: Baseline, Week 48
Mean Change in European Five-dimensional Health Scale (EQ-5D) Score From Baseline to Week 24 - LOCF
Time frame: Baseline, Week 24
Mean Change in National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) Total Score From Baseline to Week 24 - LOCF
Time frame: Baseline, Week 24
Percentage of Participants Who Were Withdrawn From Study Drug During the First 24 Weeks
Time frame: Baseline, Week 24
Mean Change in Area of Leakage From Baseline at Week 24 - LOCF
Time frame: Baseline, Week 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Bayer Study Director study director
Bayer
20 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing VEGF Trap-Eye (BAY86-5321) and No Drug in people with Myopia, Pathological, run by Bayer at 20 sites in 5 countries.
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 35 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: finished, as of the sponsor's last update on 5 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Japan, Taiwan, Hong Kong, Singapore, South Korea. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Apr 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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 Early Treatment Diabetic Retinopathy Study (ETDRS) From Baseline to Week 24 - Last Observation Carried Forward (LOCF) (time frame: Baseline, Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 May 2014.