VEGF and PEDF in Patients With Myopic Choroidal Neovascularization

Myopic Choroidal Neovascularization Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02175940
• Other study ID #: VEGF001
• Status: Completed
• Phase: N/A
• First received: June 24, 2014
• Last updated: June 25, 2014
• Start date: July 2013
• Est. completion date: May 2014

Study information

• Verified date: June 2014
• Source: Università degli Studi di Brescia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Choroidal Neovascularization
• Myopia
• Myopic Choroidal Neovascularization
• Neovascularization, Pathologic
• PEDF Aqueous Level
• VEGF Aqueous Level

Locations

Country	Name	City	State
Italy	Medical Retina Department, University of Molise	Cambpobasso	CB

Sponsors (8)

Lead Sponsor	Collaborator
Università degli Studi di Brescia	Antonio Porcellini, Ciro Costagliola, Fabiana Aceto, Francesco Semeraro, Mario R Romano, Roberto dell'Omo, Rodolfo Mastropasqua

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	vascular endothelial growth factor (VEGF) aqueous levels	VEGF aqueous levels before and after intravitreal ranibizumab	2 months	No
Primary	pigment epithelium-derived factor (PEDF) aqueous levels	PEDF aqueous levels before and after intravitreal ranibizumab	2 months
Secondary	best-corrected visual acuity		2 months	No
Secondary	central retinal thickness		2 months