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

SEQUENTIAL CLINICAL TRIAL TO EVALUATE THE EFFECTIVENESS OF INTRAVITREAL BEVACIZUMAB AS RESCUE TREATMENT OF RECURRENT MACULAR EDEMA SECONDARY TO RETINAL VEIN OCCLUSION TREATED WITH OZURDEX

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-000165-20-ES

Enrollment

Registered

2012-01-31

Start date

2012-04-13

Completion date

Unknown

Last updated

2018-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Macular edema secondary to retinal vein occlusion MedDRA version: 14.1 Level: PT Classification code 10038907 Term: Retinal vein occlusion System Organ Class: 10015919 - Eye disorders

Interventions

Trade Name: AVASTIN Pharmaceutical Form: Solution for infusion INN or Proposed INN: BEVACIZUMAB CAS Number: 216974-75-3 Concentration unit: mg milligram(s) Concentration type: equal Concentration numb

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (a) Patients = 18 years of age; (b) Who have been diagnosed with CRVO or BRVO of =65 years) yes F.1.3.1 Number of subjects for this age range 15

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Main Objective: Visual acuity (VA) gain and foveal thickness reduction by OCT. We define success in the following cases: (a) Functional success: = 3-lines gain in VA. (b) Anatomical success (measured with OCT): (b1) Full anatomical success: absence of LIR, abscence of LSR and foveal thickness less than or equal to 300 microns. (b2) Partial anatomical success: = 30% foveal thickness reduction from baseline. ;Secondary Objective: 1. To evaluate the reduction in the number of patients requiring a second Ozurdex implant. 2. To evaluate the number of intravitreal bevacizumab injections (IVB) that are required to stabilize the macular edema (ME). 3. To assess the safety of IVB in the treatment of ME due to retinal vein occlusion (RVO). 4. To identify positive predictor factors of IVB rescue treatment ;Primary end point(s): • Cuantitative evaluation of VA measured on a logarithmic scale. • Foveal thickness (measured with OCT HD-Cirrus (Carl Zeiss Meditec). ;Timepoint(s) of evaluation of this end point: 6 months	—

Measure

Time frame

Main Objective: Visual acuity (VA) gain and foveal thickness reduction by OCT. We define success in the following cases: (a) Functional success: = 3-lines gain in VA. (b) Anatomical success (measured with OCT): (b1) Full anatomical success: absence of LIR, abscence of LSR and foveal thickness less than or equal to 300 microns. (b2) Partial anatomical success: = 30% foveal thickness reduction from baseline. ;Secondary Objective: 1. To evaluate the reduction in the number of patients requiring a second Ozurdex implant. 2. To evaluate the number of intravitreal bevacizumab injections (IVB) that are required to stabilize the macular edema (ME). 3. To assess the safety of IVB in the treatment of ME due to retinal vein occlusion (RVO). 4. To identify positive predictor factors of IVB rescue treatment ;Primary end point(s): • Cuantitative evaluation of VA measured on a logarithmic scale. • Foveal thickness (measured with OCT HD-Cirrus (Carl Zeiss Meditec). ;Timepoint(s) of evaluation of this end point: 6 months

—

Secondary

Measure	Time frame
Secondary end point(s): • Safety of intravitreal bevacizumab in ME secondary to RVO treated with Ozurdex: systemic and ocular adverse events. • Number of pacientes that need a second implant of Ozurdex. • Number of IVB needed to stabilize the ME ;Timepoint(s) of evaluation of this end point: 6 months	—

Countries

Spain

Contacts

Public ContactDra Moreno López

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

mmorelop@gmail.com34913368633

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026