Macular EdemaPhase 3EBOVERNCT00970957
Safety and Effectiveness of Bevacizumab Intravitreal Injections in the Treatment of Macular Edema Secondary to Retinal Vein Occlusion
A Phase 3 study testing Avastin Intravitreal Injection in people with Macular Edema and Retinal Vein Occlusion, run by Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA at 13 sites in Spain.
Trial summary
Lack of an effective treatment for macular edema secondary to central retinal vein occlusion and the bad response to grid laser treatment in patients with macular edema secondary to branch retinal vein occlusion, together with the high incidence of the pathology and the great functional loss in the patients that… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Macular Edema, Retinal Vein Occlusion
- What is being tested?
- Avastin Intravitreal Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 107 participants
- Where
- 13 sitesSpain
- Study dates
- Sep 2009to Feb 2013
- 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 male or female 18 years old or more
- Foveal macular edema secondary to Retinal Vein Occlusion confirmed by Fluorescein angiography and Optical Coherence Tomography, with a subcentral field thickness of at least 250 microns
- Patients with best corrected visual acuity loss within the last 6 months of evolution, caused by the macular edema as stated by investigator´s judgement.
- Best corrected visual acuity tested by ETDRS within 20/40 and 20/400 in the study eye.
- Signed Informed consent.
- Signed Data Protection Consent.
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- Negative pregnancy test before entering the study for childbearing potential women, who must commit to use a medically accepted contraceptive method for the whole study.
- Macular Subcentral field assessed by Ocular coherence tomography of at least 250 microns thick.
- No presence of eye opacities that may prevent fundus exploration. No condition that may prevent correct eye dilation.
- No known allergy to fluorescein.
- Only an eye per patient will be included in the study,even if both eyes have the pathology.
Who cannot join
- Macular edema secondary to any other condition such as: diabetes retinopathy, hypertension, Juxtafoveal telangiectasia, ...
- Any previous treatment for macular edema such as photocoagulation, vitrectomy, triamcinolone, radial optic neurotomy, ... in the study eye.
- Any ocular illness thay may be associated to increased/high levels of VEGF (Age related macular degeneration, Diabetes retinopathy, Uveitis, ...)
- Systemical illnesses thay may be associated to increased/high levels of VEGF (e.g. tumours).
- Medical history of brain vascular episodes (stroke), ictus, angor pectoris or myocardial infarct within 3 months before study inclusion.
- Pregnancy or nursing.
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- Hypersensibility known or suspected to Bevacizumab, his excipients or any related molecule.
- Uncontrolled hypertension refractary to medical treatment.
- Participation in any other trial or study within the last 3 months (minerals and vitamins excluded) or treatment with anti-VEGF in the non-study eye within the previous 3 months.
- Tractional maculopathy and/or epiretinal membrane assessed by Ocular Coherence Tomography.
- Media opacities that don´t allow correct eye exploration and fundus examination/photographs.
- Cataract surgery / Yag capsulotomy within the previous 6 months.
- Filtration surgery.
- Previous medical history of ocular illnesses as: viral infections, inflammatory pathology, serous central choroidopathy, retinal detachment or any other illness that may have an influence in visual acuity.
- Presence of foveal atrophy, severe pigmentary changes, dense subfoveal haemorrhages, confluent subfoveal hard exudates or any other condition that may influence functional recovery of the macular edema.
- Cataract that may be responsible for additional visual acuity loss of more than 2/10.
- Medically uncontrolled intraocular pressure higher than 25 mm Hg.
- External ocular illnesses active at inclusion as: conjunctivitis, blepharitis, eye sore, ...
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
Spain13 sites
Instituto Oftalmológico de Alicante
Alicante, Alicante, 03015
Hospital de la Vall D´Hebrón
Barcelona, Barcelona, 08022
Hospital Clinic
Barcelona, Barcelona, 08036
Hospital General Reina Sofía
Espinardo, Murcia, 30100
Hospital Clínico San Carlos
Madrid, Madrid, 28010
Hospital Ramón y Cajal
Madrid, Madrid, 28034
Hospital La Paz
Madrid, Madrid, 28046
Clínica Universitaria de Navarra
Pamplona, Navarre, 31080
Hospital Provincial Conxo - Fundación IDICHUS
Santiago de Compostela, La Coruña, 15706
Hospital Virgen de la Macarena
Seville, Sevilla, 41009
Hospital Virgen de Valme
Seville, Sevilla, 41014
Hospital General Universitario de Valencia
Valencia, Valencia, 46014
Instituto Universitario de Oftalmobiología Aplicada
Valladolid, Valladolid, 47011
About this study
Official title: Study of the Safety and Efficacy of Bevacizumab Intravitreal Injections for the Treatment of Macular Edema Secondary to Retinal Vein Occlusions
Lack of an effective treatment for macular edema secondary to central retinal vein occlusion and the bad response to grid laser treatment in patients with macular edema secondary to branch retinal vein occlusion, together with the high incidence of the pathology and the great functional loss in the patients that suffer from it has motivated the search for new therapeutic approaches.
In recent times, intravitreal bevacizumab has been tested in clinical practice in small series of patients with this pathology, whether as first treatment or after failure of grid laser treatment with good functional results in short series.
However, no retreatment information is available, although preliminary results from published series are good.
- Conditions
- Macular Edema, Retinal Vein Occlusion
- Being tested
- Avastin Intravitreal Injection, Sham Avastin Intravitreal Injection
- Keywords
- Macular edema, Retinal Vein Occlusion, Bevacizumab
- Medical subject headings
- Macular Edema, Retinal Vein Occlusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Avastin Intravitreal InjectionDrug
Also called Avastin
Intravitreal injection of 1.25mg Avastin (Bevacizumab) per month, during the first 3 months. Retreatments will be required if visual acuity or macular edema thickness worsen as defined per protocol
Sham Avastin Intravitreal InjectionDrug
Also called Sham
Intravitreal Injection simulation with a syringe without needle. The rest of the procedure remains the same as if intravitreal injection were to be performed (antibiotic prophylaxis, local anesthesia, ...).
| Study group | Role | What they receive |
|---|---|---|
| Central RVO - Macular edema - Avastin | Experimental | Patients with Macular edema secondary to CENTRAL Retinal Vein Occlusion that will be treated with intravitreal injection of avastin once per month during the first 3 months. Re-treatments will be given as per protocol. Receives: Drug: Avastin Intravitreal Injection |
| Central RVO - Macular edema - Sham | Sham comparator | Patients with Macular edema secondary to CENTRAL Retinal Vein Occlusion that will have a sham procedure performed. Injection without needle. Receives: Drug: Sham Avastin Intravitreal Injection |
| Branch RVO - Macular edema - Avastin | Experimental | Patients with Macular edema secondary to BRANCH Retinal Vein Occlusion that will be treated with intravitreal injection of avastin once per month during the first 3 months. Re-treatments will be given as per protocol. Receives: Drug: Avastin Intravitreal Injection |
| Branch RVO - Macular edema - Sham | Sham comparator | Patients with Macular edema secondary to BRANCH Retinal Vein Occlusion that will have a sham procedure performed. Injection without needle. Receives: Drug: Sham Avastin Intravitreal Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best corrected visual acuity assessed as described in the Early Treatment for Diabetes Retinopathy Study (ETDRS)
Measured: 1 month
Secondary outcomes (1)
Macular Subcentral Field Thickness assessed by Ocular coherence tomography
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2009 (estimated)
- Study startSep 2009
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Macular EdemaStudies 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, Outcomes assessor
- Enrolment
- 107 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
- María Isabel López Gálvez, MD, PhD, Principal investigator, IOBA - Instituto Universitario de Oftalmobiología Aplicada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00970957
- Sponsor's protocol ID
- IOBA-03-2008
- Other IDs
- EUDRA -CT 2008-005789-30
- Acronym
- EBOVER
- Status last verified
- Mar 2014
- First submitted
- 2 Sep 2009
- Last updated
- 19 Mar 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Safety and Efficacy of Bevacizumab Intravitreal Injections for the Treatment of Macular Edema Secondary to Retinal Vein Occlusions
- ClinicalTrials.gov ID
- NCT00970957
- Acronym / sponsor ID
- EBOVER / IOBA-03-2008
- Conditions
- Macular Edema, Retinal Vein Occlusion
- Keywords
- Macular edema, Retinal Vein Occlusion, Bevacizumab
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBAUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 3 Sep 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.
Lack of an effective treatment for macular edema secondary to central retinal vein occlusion and the bad response to grid laser treatment in patients with macular edema secondary to branch retinal vein occlusion, together with the high incidence of the pathology and the great functional loss in the patients that suffer from it has motivated the search for new therapeutic approaches.
In recent times, intravitreal bevacizumab has been tested in clinical practice in small series of patients with this pathology, whether as first treatment or after failure of grid laser treatment with good functional results in short series.
However, no retreatment information is available, although preliminary results from published series are good.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Central RVO - Macular edema - Avastin | Experimental | Drug: Avastin Intravitreal InjectionPatients with Macular edema secondary to CENTRAL Retinal Vein Occlusion that will be treated with intravitreal injection of avastin once per month during the first 3 months. Re-treatments will be given as per protocol. |
| Central RVO - Macular edema - Sham | Sham comparator | Drug: Sham Avastin Intravitreal InjectionPatients with Macular edema secondary to CENTRAL Retinal Vein Occlusion that will have a sham procedure performed. Injection without needle. |
| Branch RVO - Macular edema - Avastin | Experimental | Drug: Avastin Intravitreal InjectionPatients with Macular edema secondary to BRANCH Retinal Vein Occlusion that will be treated with intravitreal injection of avastin once per month during the first 3 months. Re-treatments will be given as per protocol. |
| Branch RVO - Macular edema - Sham | Sham comparator | Drug: Sham Avastin Intravitreal InjectionPatients with Macular edema secondary to BRANCH Retinal Vein Occlusion that will have a sham procedure performed. Injection without needle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patient male or female 18 years old or more
- Foveal macular edema secondary to Retinal Vein Occlusion confirmed by Fluorescein angiography and Optical Coherence Tomography, with a subcentral field thickness of at least 250 microns
- Patients with best corrected visual acuity loss within the last 6 months of evolution, caused by the macular edema as stated by investigator´s judgement.
- Best corrected visual acuity tested by ETDRS within 20/40 and 20/400 in the study eye.
- Signed Informed consent.
Key exclusion criteria (18 listed)
- Macular edema secondary to any other condition such as: diabetes retinopathy, hypertension, Juxtafoveal telangiectasia, ...
- Any previous treatment for macular edema such as photocoagulation, vitrectomy, triamcinolone, radial optic neurotomy, ... in the study eye.
- Any ocular illness thay may be associated to increased/high levels of VEGF (Age related macular degeneration, Diabetes retinopathy, Uveitis, ...)
- Systemical illnesses thay may be associated to increased/high levels of VEGF (e.g. tumours).
- Medical history of brain vascular episodes (stroke), ictus, angor pectoris or myocardial infarct within 3 months before study inclusion.
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 |
|---|---|---|
| Avastin Intravitreal InjectionAlso: AvastinIntravitreal injection of 1.25mg Avastin (Bevacizumab) per month, during the first 3 months. Retreatments will be required if visual acuity or macular edema thickness worsen as defined per protocol | Drug | Branch RVO - Macular edema - Avastin, Central RVO - Macular edema - Avastin |
| Sham Avastin Intravitreal InjectionAlso: ShamIntravitreal Injection simulation with a syringe without needle. The rest of the procedure remains the same as if intravitreal injection were to be performed (antibiotic prophylaxis, local anesthesia, ...). | Drug | Branch RVO - Macular edema - Sham, Central RVO - Macular edema - Sham |
Primary outcome
Best corrected visual acuity assessed as described in the Early Treatment for Diabetes Retinopathy Study (ETDRS)
Time frame: 1 month
1 secondary outcome
Macular Subcentral Field Thickness assessed by Ocular coherence tomography
Time frame: 1 month
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 19 Mar 2014.
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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.
María Isabel López Gálvez, MD, PhD principal investigator
IOBA - Instituto Universitario de Oftalmobiología Aplicada
13 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 Avastin Intravitreal Injection in people with Macular Edema and Retinal Vein Occlusion, run by Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA at 13 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 11 inclusion and 18 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 19 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 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. 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?
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?
Best corrected visual acuity assessed as described in the Early Treatment for Diabetes Retinopathy Study (ETDRS) (time frame: 1 month). 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 19 Mar 2014.