VEGF and PEDF in Patients With Myopic Choroidal Neovascularization

NCT02175940 | Completed

• 1 other identifier: VEGF001
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Myopic Choroidal Neovascularization; VEGF Aqueous Level; PEDF Aqueous Level

Outcome Measures

Primary Outcomes (2)

• vascular endothelial growth factor (VEGF) aqueous levels

  VEGF aqueous levels before and after intravitreal ranibizumab

  2 months

• pigment epithelium-derived factor (PEDF) aqueous levels

  PEDF aqueous levels before and after intravitreal ranibizumab

  2 months

Secondary Outcomes (2)

• best-corrected visual acuity

  2 months

• central retinal thickness

  2 months

Study Arms (2)

Myopic Choroidal Neovascularization patients

Control patients undergoing cataract surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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;

You may not qualify if:

• 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

Sponsors & Collaborators

• Università degli Studi di Brescia: lead
• Ciro Costagliola: collaborator
• Francesco Semeraro: collaborator
• Roberto dell'Omo: collaborator
• Mario R Romano: collaborator
• Fabiana Aceto: collaborator
• Rodolfo Mastropasqua: collaborator
• Antonio Porcellini: collaborator

Study Sites (1)

Medical Retina Department, University of Molise

Cambpobasso, CB, 86100, Italy

Location

Related Publications (1)

• Costagliola C, Semeraro F, dell'Omo R, Romano MR, Russo A, Aceto F, Mastropasqua R, Porcellini A. Effect of intravitreal ranibizumab injections on aqueous humour concentrations of vascular endothelial growth factor and pigment epithelium-derived factor in patients with myopic choroidal neovascularisation. Br J Ophthalmol. 2015 Jul;99(7):1004-8. doi: 10.1136/bjophthalmol-2014-306465. Epub 2015 Mar 13.

  PMID: 25770144 DERIVED

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD Researcher

Study Record Dates

• First Submitted: June 24, 2014
• First Posted: June 26, 2014
• Study Start: July 1, 2013
• Primary Completion: January 1, 2014
• Study Completion: May 1, 2014
• Last Updated: June 26, 2014

Record last verified: 2014-06

Locations

IT (1)