Trials Sponsors Conditions Drugs Pricing

Conditions

Choroidal Subfoveal/Juxtafoveal Neovascularization in High Myopia

Keywords

high myopiachoroidal neovascularization

Outcome Measures

Primary Outcomes (3)

Early Treatment Diabetic Retinopathy Study (ETDRS) Best corrected visual acuity
Differences in best corrected visual acuity in the exit visit compared to the one obtained at screening visit
1 Year
Retinal thickness
Retinal thickness assessed by Spectral Domain Optical Coherence Tomography
1 Year
Number of total injections during study
Total count of bevacizumab intravitreal injections during the whole study
1 Year

Study Arms (2)

3 Month Load with 9 month p.r.n.

ACTIVE COMPARATOR

3 Monthly bevacizumab injections with 9 p.r.n. monthly doses if patient meets the treatment criteria for each monthly visit

Drug: Bevazizumab intravitreal injection

Single Dose Load Phase

EXPERIMENTAL

Single dose treatment with bevacizumab, followed by 2 sham injections if conditions are met in the months 2 and 3, and followed with bevacizumab monthly p.r.n. as per protocol

Drug: Bevazizumab intravitreal injection

Interventions

Bevazizumab intravitreal injectionDrug

Intravitreal injection of bevacizumab

Also known as: Avastin Injection

3 Month Load with 9 month p.r.n.Single Dose Load Phase

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Active subfoveal/juxtafoveal choroidal neovascularization in high myopia confirmed by Fundus Fluorescein angiography and Optical Coherence Tomography
Best corrected visual acuity loss with less than 6 months of evolution, caused mainly by the neovascular lesion (based in investigator´s criteria)

Sponsors & Collaborators

Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA
Otherlead

Study Sites (11)

CHUS - Fundacion IDICHUS

Santiago de Compostela, La Coruña, 15706, Spain

Clinica Universitaria de Navarra

Pamplona, Navarre, 31080, Spain

Complejo Hospitalario de Albacete

Albacete, 02006, Spain

Hospital Clinico Universitario San Carlos

Madrid, 28010, Spain

Hospital Universitario Ramón y Cajal

Madrid, 28031, Spain

Hospital Reina Sofia

Murcia, 30100, Spain

Hospital Virgen de Valme

Seville, 41013, Spain

MeSH Terms

Conditions

Choroidal Neovascularization

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

Choroid DiseasesUveal DiseasesEye DiseasesNeovascularization, PathologicMetaplasiaPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodies

Study Officials

Jose Maria Ruiz-Moreno, MD PhD
University of Castilla-La Mancha
PRINCIPAL INVESTIGATOR

Enrollment

66 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: DOUBLE
Who Masked: PARTICIPANT, INVESTIGATOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

October 25, 2012

First Posted

October 29, 2012

Study Start

October 2012

Actual (reported)

Initial Treatment With Bevacizumab in Choroidal Neovascularization Associated to High Myopia

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (3)

Study Arms (2)

3 Month Load with 9 month p.r.n.

Single Dose Load Phase

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (11)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (3)

Study Arms (2)

3 Month Load with 9 month p.r.n.

Single Dose Load Phase

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (11)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations