Choroidal Subfoveal/Juxtafoveal Neovascularization in High MyopiaPhase 3BENEMCORNCT01716026
Initial Treatment With Bevacizumab in Choroidal Neovascularization Associated to High Myopia
A Phase 3 study testing Bevazizumab intravitreal injection in people with Choroidal Subfoveal/Juxtafoveal Neovascularization in High Myopia, run by Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA at 11 sites in Spain.
Trial summary
The purpose of this protocol is to determine wether the initial protocol in the treatment of subfoveal choroidal neovascularization associated to High Myopia with bevacizumab intravitreal injections is more effective when using 3 doses vs using 1 single dose in the load period Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Choroidal Subfoveal/Juxtafoveal Neovascularization in High Myopia
- What is being tested?
- Bevazizumab intravitreal injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 11 sitesSpain
- Study dates
- Oct 2012to Apr 2018
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Active subfoveal/juxtafoveal choroidal neovascularization in high myopia confirmed by Fundus Fluorescein angiography and Optical Coherence Tomography
- Best corrected visual acuity loss with less than 6 months of evolution, caused mainly by the neovascular lesion (based in investigator´s criteria)
- No atrophy or fibrotic component that may prevent visual acuity improvement
- Patients previously treated with Photodynamic Therapy are allowed to participate in this study
- Signed informed consent
- Signed data protection consent
- Negative pregnancy test in potential childbearing women at screening, with accepted contraceptive method during the whole study
Who cannot join
- Previous vitreous surgery in study eye
- Tractional maculopathy or epiretinal membrane found in Optical Coherence Tomography
- Media opacities that may prevent correct fundus assessment
- Lack of posterior capsule integrity in pseudophakic patients
- Patients with great possibilities of not being able to attend to study visits / follow visit procedures (investigator´s criteria)
- Patients previously treated with intravitreal antiangiogenic injections
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Spain11 sites
Complejo Hospitalario de Albacete
Albacete, 02006
Hospital Clinico Universitario San Carlos
Madrid, 28010
Hospital Universitario Ramón y Cajal
Madrid, 28031
Hospital Reina Sofia
Murcia, 30100
Clinica Universitaria de Navarra
Pamplona, Navarre, 31080
CHUS - Fundacion IDICHUS
Santiago de Compostela, La Coruña, 15706
Hospital Virgen de Valme
Seville, 41013
Hospital Virgen de la Macarena
Seville, 41071
Hospital General Universitario de Valencia
Valencia
IOBA - Instituto Universitario de Oftalmobiologia Aplicada
Valladolid, 47011
Hospital Universitario Rio Hortega
Valladolid, 47012
About this study
Official title: Establishment of the Initial Protocol With Intravitreal Bevacizumab for the Treatment of Choroidal Neovascularization Associated With High Myopia:3 vs 1.
The purpose of this protocol is to determine wether the initial protocol in the treatment of subfoveal choroidal neovascularization associated to High Myopia with bevacizumab intravitreal injections is more effective when using 3 doses vs using 1 single dose in the load period
- Being tested
- Bevazizumab intravitreal injection
- Keywords
- high myopia, choroidal neovascularization
- Medical subject headings
- Choroidal Neovascularization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bevazizumab intravitreal injectionDrug
Also called Avastin Injection
Intravitreal injection of bevacizumab
| Study group | Role | What they receive |
|---|---|---|
| 3 Month Load with 9 month p.r.n. | Active comparator | 3 Monthly bevacizumab injections with 9 p.r.n. monthly doses if patient meets the treatment criteria for each monthly visit Receives: Drug: Bevazizumab intravitreal injection |
| Single Dose Load Phase | Experimental | Single dose treatment with bevacizumab, followed by 2 sham injections if conditions are met in the months 2 and 3, and followed with bevacizumab monthly p.r.n. as per protocol Receives: Drug: Bevazizumab intravitreal injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early Treatment Diabetic Retinopathy Study (ETDRS) Best corrected visual acuity
Differences in best corrected visual acuity in the exit visit compared to the one obtained at screening visit
Measured: 1 Year
Retinal thickness
Retinal thickness assessed by Spectral Domain Optical Coherence Tomography
Measured: 1 Year
Number of total injections during study
Total count of bevacizumab intravitreal injections during the whole study
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2012 (estimated)
- Study startOct 2012
- Primary completionApr 2018
- Study completionApr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Choroidal Subfoveal/Juxtafoveal Neovascularization in High 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jose Maria Ruiz-Moreno, MD PhD, Principal investigator, University of Castilla-La Mancha
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01716026
- Sponsor's protocol ID
- IOBA-04-2012
- Acronym
- BENEMCOR
- Status last verified
- Jun 2021
- First submitted
- 25 Oct 2012
- Last updated
- 13 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment of the Initial Protocol With Intravitreal Bevacizumab for the Treatment of Choroidal Neovascularization Associated With High Myopia:3 vs 1.
- ClinicalTrials.gov ID
- NCT01716026
- Acronym / sponsor ID
- BENEMCOR / IOBA-04-2012
- Keywords
- high myopia, choroidal neovascularization
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBAUniversity, hospital or other
- Study start
- Oct 2012 (actual)
- Primary completion
- Apr 2018 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 29 Oct 2012 (estimated)
- 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 protocol is to determine wether the initial protocol in the treatment of subfoveal choroidal neovascularization associated to High Myopia with bevacizumab intravitreal injections is more effective when using 3 doses vs using 1 single dose in the load period
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3 Month Load with 9 month p.r.n. | Active comparator | Drug: Bevazizumab intravitreal injection3 Monthly bevacizumab injections with 9 p.r.n. monthly doses if patient meets the treatment criteria for each monthly visit |
| Single Dose Load Phase | Experimental | Drug: Bevazizumab intravitreal injectionSingle dose treatment with bevacizumab, followed by 2 sham injections if conditions are met in the months 2 and 3, and followed with bevacizumab monthly p.r.n. as per protocol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Active subfoveal/juxtafoveal choroidal neovascularization in high myopia confirmed by Fundus Fluorescein angiography and Optical Coherence Tomography
- Best corrected visual acuity loss with less than 6 months of evolution, caused mainly by the neovascular lesion (based in investigator´s criteria)
- No atrophy or fibrotic component that may prevent visual acuity improvement
- Patients previously treated with Photodynamic Therapy are allowed to participate in this study
- Signed informed consent
Key exclusion criteria (6 listed)
- Previous vitreous surgery in study eye
- Tractional maculopathy or epiretinal membrane found in Optical Coherence Tomography
- Media opacities that may prevent correct fundus assessment
- Lack of posterior capsule integrity in pseudophakic patients
- Patients with great possibilities of not being able to attend to study visits / follow visit procedures (investigator´s criteria)
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 |
|---|---|---|
| Bevazizumab intravitreal injectionAlso: Avastin InjectionIntravitreal injection of bevacizumab | Drug | 3 Month Load with 9 month p.r.n., Single Dose Load Phase |
Primary outcome
Early Treatment Diabetic Retinopathy Study (ETDRS) Best corrected visual acuity
Time frame: 1 Year
Differences in best corrected visual acuity in the exit visit compared to the one obtained at screening visit
Retinal thickness
Time frame: 1 Year
Retinal thickness assessed by Spectral Domain Optical Coherence Tomography
Number of total injections during study
Time frame: 1 Year
Total count of bevacizumab intravitreal injections during the whole study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2023.
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.
Jose Maria Ruiz-Moreno, MD PhD principal investigator
University of Castilla-La Mancha
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bevazizumab intravitreal injection in people with Choroidal Subfoveal/Juxtafoveal Neovascularization in High Myopia, run by Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA at 11 sites in Spain.
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 7 inclusion and 6 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 13 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Spain. 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.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Early Treatment Diabetic Retinopathy Study (ETDRS) Best corrected visual acuity (time frame: 1 Year). The study lists 3 primary outcomes in all. 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 13 Mar 2023.