VEGF and PEDF in Patients With Myopic Choroidal Neovascularization

June 25, 2014 updated by: Andrea Russo, Università degli Studi di Brescia

Effect of Intravitreal Ranibizumab Injection on Aqueous Humor Concentrations of Vascular Endothelial Growth Factor and Pigment Epithelium-derived Factor in Patients With Myopic Choroidal Neovascularization.

This was a prospective, case-control study investigating aqueous levels of VEGF and PEDF in eyes with mCNV treated with IVB.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • CB
      • Cambpobasso, CB, Italy, 86100
        • Medical Retina Department, University of Molise

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with myopic Choroidal Neovascularization treated with intravitreal ranibizumab at the Medical Retina Department, University of Molise, Campobasso, Italy

Description

Inclusion Criteria:

  • pathologic myopia, defined as spherical equivalent >6 diopters and axial length >26 mm
  • posterior pole myopic retinal changes (posterior staphyloma, chorioretinal atrophy, papillary crescent);
  • fluorescein angiography, indocyanine green angiography and optical coherence tomography detection of the subfoveal or juxtafoveal choroidal neovascularization
  • clear ocular media;

Exclusion Criteria:

  • previous treatment for choroidal neovascularization, including the previous intravitreal drug injection or PDT
  • presence of other maculopathy as diabetic retinopathy or retinal vascular occlusion
  • history of recent myocardial infarction or other thromboembolic events
  • ongoing uncontrolled hypertension or glaucoma
  • refractive media opacities
  • previous eye surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Myopic Choroidal Neovascularization patients
Control patients undergoing cataract surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
vascular endothelial growth factor (VEGF) aqueous levels
Time Frame: 2 months
VEGF aqueous levels before and after intravitreal ranibizumab
2 months
pigment epithelium-derived factor (PEDF) aqueous levels
Time Frame: 2 months
PEDF aqueous levels before and after intravitreal ranibizumab
2 months

Secondary Outcome Measures

Outcome Measure
Time Frame
best-corrected visual acuity
Time Frame: 2 months
2 months
central retinal thickness
Time Frame: 2 months
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Università degli Studi di Brescia

Collaborators

Ciro Costagliola
Francesco Semeraro
Roberto dell'Omo
Mario R Romano
Fabiana Aceto
Rodolfo Mastropasqua
Antonio Porcellini

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

June 24, 2014

First Submitted That Met QC Criteria

June 25, 2014

First Posted (Estimate)

June 26, 2014

Study Record Updates

Last Update Posted (Estimate)

June 26, 2014

Last Update Submitted That Met QC Criteria

June 25, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VEGF001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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