MyopiaPhase 3NCT00967850
Efficacy and Safety of Intravitreal Bevacizumab in the Treatment of Choroidal Neovascular Membranes Associated to High Myopia
A Phase 3 study testing Intravitreal Injection and Photodynamic Therapy (Visudyne) in people with Myopia and Choroidal Neovascularization, run by Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA at 7 sites in Spain.
Trial summary
The purpose of this study is to determine the efficacy and safety of intravitreal injections of bevacizumab in High Myopia´s choroidal neovascularization versus the standard treatment of Photodynamic therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myopia, Choroidal Neovascularization
- What is being tested?
- Intravitreal Injection and Photodynamic Therapy (Visudyne)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 7 sitesSpain
- Study dates
- Apr 2008to Jun 2011
- 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
- Patient at least 18 years old
- High Myopia with one of the following:
- 6 or more sphere diopters in the study eye
- Axial length of the eye greater than 26 millimeters
- Active subfoveal/juxtafoveal choroidal neovascularization confirmed by Fluorescein angiography and Ocular coherence tomography.
- Visual acuity loss of less than 6 months of evolution related to the neovascular lesion, as stated by investigator´s opinion.
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- Patients previously treated with Photodynamic therapy are allowed to participate as long as the last treatment has been performed more than 3 months upon entering the study.
- Signed informed consent.
- Signed data protection consent.
- Women of childbearing potential must provide a negative pregnancy test at inclusion and must commit to the use of a contraceptive treatment during the whole study.
Who cannot join
- Previous vitrectomy surgery in the study eye.
- Tractional maculopathy and/or epiretinal membrane evaluated by Ocular coherence tomography.
- Opacities that may not allow correct fundus assessment.
- Lack of integrity of the posterior lens capsule in pseudoaphakic patients.
- Patients that may not want/be able to complete the study, based in the investigator opinion.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Spain7 sites
Instituto Oftalmológico de Alicante
Alicante, 03015
Hospital de la Vall d´Hebron
Barcelona, 08022
Hospital General Reina Sofía
Espinardo, Murcia, 30100
Hospital Clínico San Carlos
Madrid, 28010
Clínica Universitaria de Navarra
Pamplona, Navarre, 31080
INGO
Santiago de Compostela, La Coruña, 15706
IOBA - Instituto Universitario de Oftalmobiología Aplicada
Valladolid, 47011
About this study
Official title: Phase III Study of Efficacy and Safety of Intravitreal Bevacizumab in the Treatment of Choroidal Neovascular Membranes Associated to High Myopia
The purpose of this study is to determine the efficacy and safety of intravitreal injections of bevacizumab in High Myopia´s choroidal neovascularization versus the standard treatment of Photodynamic therapy.
Read the detailed description
Bad response in choroidal neovascularization in High myopia to Photodynamic therapy, which is the current approved treatment for that pathology, and the high incidence of this pathology in these patients, together with the great functional impact in their vision has fostered the search for new therapeutic strategies.
Intravitreal bevacizumab has already been tested in small series of patients with choroidal neovascularization associated to high myopia, whether as first treatment option or after the failure of photodynamic therapy with good results. In the published series an improvement of visual acuity is described after 1-2 injections, with a reduction in the macular edema and a good safety profile.
The lack of published trials that describe the efficacy of frequency of treatment in this pathology is the main reason for this trial.
- Conditions
- Myopia, Choroidal Neovascularization
- Being tested
- Intravitreal Injection, Photodynamic Therapy (Visudyne)
- Keywords
- High Myopia, Bevacizumab, Photodynamic therapy
- Medical subject headings
- Myopia, Choroidal Neovascularization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravitreal InjectionDrug
Also called Avastin
Intravitreal injection of 1,25 mg in 0,05 ml
Photodynamic Therapy (Visudyne)Drug
Photodynamic therapy on day 1 as described in standard clinical guidelines.
| Study group | Role | What they receive |
|---|---|---|
| Intravitreal Bevacizumab | Experimental | Intravitreal injections of bevacizumab Receives: Drug: Intravitreal Injection |
| Visudyne | Active comparator | Photodynamic Therapy with Visudyne Receives: Drug: Photodynamic Therapy (Visudyne) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in Visual Acuity assessed by ETDRS
Measured: Every month during first year - Every three months during the second year
Secondary outcomes (2)
Central macular thickness with Ocular Coherence Tomography
Measured: Every month during first year - Every three months during the second year
Complications that may arise from intravitreal injection
Measured: Every treatment visit - Once per month during the first 3 months. Reteatments depending on Visual acuitiy evolution and retinal thickness
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2009 (estimated)
- Study startApr 2008
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA
- Sponsor type
- University, hospital or other
- Collaborators
- Fondo de Investigacion Sanitaria
- Responsible party
- Sponsor
- Investigators
- José Carlos Pastor Jimeno, MD, PhD, Principal investigator, IOBA - Instituto Universitario de Oftalmobiología Aplicada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00967850
- Sponsor's protocol ID
- IOBA-002-2007
- Other IDs
- EUDRA CT 2007-006785-15
- Status last verified
- Aug 2009
- First submitted
- 24 Aug 2009
- Last updated
- 31 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Study of Efficacy and Safety of Intravitreal Bevacizumab in the Treatment of Choroidal Neovascular Membranes Associated to High Myopia
- ClinicalTrials.gov ID
- NCT00967850
- Acronym / sponsor ID
- IOBA-002-2007
- Conditions
- Myopia, Choroidal Neovascularization
- Keywords
- High Myopia, Bevacizumab, Photodynamic therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBAUniversity, hospital or other
- Collaborators
- Fondo de Investigacion Sanitaria
- Study start
- Apr 2008
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 28 Aug 2009 (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 study is to determine the efficacy and safety of intravitreal injections of bevacizumab in High Myopia´s choroidal neovascularization versus the standard treatment of Photodynamic therapy.
Detailed description
Bad response in choroidal neovascularization in High myopia to Photodynamic therapy, which is the current approved treatment for that pathology, and the high incidence of this pathology in these patients, together with the great functional impact in their vision has fostered the search for new therapeutic strategies.
Intravitreal bevacizumab has already been tested in small series of patients with choroidal neovascularization associated to high myopia, whether as first treatment option or after the failure of photodynamic therapy with good results. In the published series an improvement of visual acuity is described after 1-2 injections, with a reduction in the macular edema and a good safety profile.
The lack of published trials that describe the efficacy of frequency of treatment in this pathology is the main reason for this trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intravitreal Bevacizumab | Experimental | Drug: Intravitreal InjectionIntravitreal injections of bevacizumab |
| Visudyne | Active comparator | Drug: Photodynamic Therapy (Visudyne)Photodynamic Therapy with Visudyne |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patient at least 18 years old
- High Myopia with one of the following:
- Active subfoveal/juxtafoveal choroidal neovascularization confirmed by Fluorescein angiography and Ocular coherence tomography.
- Visual acuity loss of less than 6 months of evolution related to the neovascular lesion, as stated by investigator´s opinion.
- Patients previously treated with Photodynamic therapy are allowed to participate as long as the last treatment has been performed more than 3 months upon entering the study.
Key exclusion criteria (5 listed)
- Previous vitrectomy surgery in the study eye.
- Tractional maculopathy and/or epiretinal membrane evaluated by Ocular coherence tomography.
- Opacities that may not allow correct fundus assessment.
- Lack of integrity of the posterior lens capsule in pseudoaphakic patients.
- Patients that may not want/be able to complete the study, based in the investigator opinion.
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: AvastinIntravitreal injection of 1,25 mg in 0,05 ml | Drug | Intravitreal Bevacizumab |
| Photodynamic Therapy (Visudyne)Photodynamic therapy on day 1 as described in standard clinical guidelines. | Drug | Visudyne |
Primary outcome
Improvement in Visual Acuity assessed by ETDRS
Time frame: Every month during first year - Every three months during the second year
2 secondary outcomes
Central macular thickness with Ocular Coherence Tomography
Time frame: Every month during first year - Every three months during the second year
Complications that may arise from intravitreal injection
Time frame: Every treatment visit - Once per month during the first 3 months. Reteatments depending on Visual acuitiy evolution and retinal thickness
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 31 Oct 2024.
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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.
José Carlos Pastor Jimeno, MD, PhD principal investigator
IOBA - Instituto Universitario de Oftalmobiología Aplicada
7 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 Intravitreal Injection and Photodynamic Therapy (Visudyne) in people with Myopia and Choroidal Neovascularization, run by Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA at 7 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 10 inclusion and 5 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 31 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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?
Improvement in Visual Acuity assessed by ETDRS (time frame: Every month during first year - Every three months during the second year). 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 31 Oct 2024.