Clinical trial to evaluate the results of intravitreal bevacizumab injections in cases of recurrence of macular edema secondary to retinal vein thrombosis previously treated with ozurdex

Phase 1

Conditions: Macular edema secondary to retinal vein occlusion
MedDRA version: 14.1Level: PTClassification code 10038907Term: Retinal vein occlusionSystem Organ Class: 10015919 - Eye disorders
Therapeutic area: Diseases [C] - Eye Diseases [C11]

Registration Number: EUCTR2012-000165-20-ES

Lead Sponsor: Fundación para la Investigación biomédica del Hospital Universitario Ramón y Cajal. Madrid

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 53

Inclusion Criteria

(a)Patients = 18 years of age;
(b)Who have been diagnosed with CRVO or BRVO of <1 year of evolution;
(c)Subjects who have been treated for ME secondary to RVO with a single Ozurdex implant within 6 months and who have recurrence or persistence of ME at 2 months following Ozurdex implant.
(d)Patients who have received thorough information on the design, the purpose of the study, the potential risks and understand their rigths to refuse to participate in the study at any time, and have signed the informed consent document.
(e)Patients who understand the purpose of the study and are available to make the necessary follow-up visits.
(f) Both in the case of female and male patients, the patient agrees to use
a double barrier method of contraception from the moment of signing
the informed consent until 6 months after the end of their participation
in the study
(g) negative pregnancy test
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 53
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15

Exclusion Criteria

(f)Subjects who have received oral or intravitreal treatment for ME in the 4 months prior to Ozurdex implant.

(g)Subjects who have undergone laser ophthalmic treatment or eye surgery within 4 months prior to OZURDEX.

(h)Subjects having any systemic disease that prevents the use of BIV (pregnancy, lactation, uncontrolled hypertension, diabetic retinopathy or uncontrolled systemic disease).

(i)Subjects on topical prostaglandin analogues for ocular hipertension.

(j)Allergy to any component of Avastin.

(k)The presence of clinically significant vitreoretinal traction or macular epiretinal membrane on OCT.

(l)The presence of optic disc or retinal neovascularization, past or active choroidal neovascularization, active eye infection, aphakia or anterior chamber intraocular lens or significant media opacity.

(m)Any eye condition that to the investigator's discretion may prevent a = 3- line gain in VA.

(n) Pregnancy o breast feeding
(o) To have contraindications or limitations to bevacizumab