Safety and Effectiveness of Bevacizumab Intravitreal Injections in the Treatment of Macular Edema Secondary to Retinal Vein Occlusion
Information source: Instituto Universitario de Oftalmobiología Aplicada
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Macular Edema; Retinal Vein Occlusion
Intervention: Avastin Intravitreal Injection (Drug); Sham Avastin Intravitreal Injection (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Instituto Universitario de Oftalmobiología Aplicada Official(s) and/or principal investigator(s): MarĂa Isabel LĂłpez Gálvez, MD, PhD, Principal Investigator, Affiliation: IOBA - Instituto Universitario de OftalmobiologĂa Aplicada
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 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.
Clinical Details
Official title: Study of the Safety and Efficacy of Bevacizumab Intravitreal Injections for the Treatment of Macular Edema Secondary to Retinal Vein Occlusions
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Best corrected visual acuity assessed as described in the Early Treatment for Diabetes Retinopathy Study (ETDRS)
Secondary outcome: Macular Subcentral Field Thickness assessed by Ocular coherence tomography
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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.
- 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.
Exclusion Criteria:
- 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.
- 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, ...
Locations and Contacts
Instituto OftalmolĂłgico de Alicante, Alicante 03015, Spain
Hospital Clinic, Barcelona 08036, Spain
Hospital de la Vall D´Hebrón, Barcelona 08022, Spain
Hospital ClĂnico San Carlos, Madrid 28010, Spain
Hospital La Paz, Madrid 28046, Spain
Hospital RamĂłn y Cajal, Madrid 28034, Spain
Hospital Virgen de la Macarena, Sevilla 41009, Spain
Hospital Virgen de Valme, Sevilla 41014, Spain
Hospital General Universitario de Valencia, Valencia 46014, Spain
Instituto Universitario de OftalmobiologĂa Aplicada, Valladolid 47011, Spain
Hospital Provincial Conxo - Fundación IDICHUS, Santiago de Compostela, La Coruña 15706, Spain
Hospital General Reina SofĂa, Espinardo, Murcia 30100, Spain
ClĂnica Universitaria de Navarra, Pamplona, Navarra 31080, Spain
Additional Information
Starting date: September 2009
Last updated: March 18, 2014
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