The Effect of a Single Intravitreal Anti-VEGF Therapy on Optic Nerve Head Perfusion

NCT00709657 | Terminated DMC

• 1 other identifier: OPHT-060707
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

Age related macula degeneration is one of the most common sight threatening diseases of the elderly. The so called wet form of AMD is caused by choroidal neovascularisation (CNV) of pathological vessels, which lead to leakage, bleeding and macular edema. Several lines of evidence suggest that vascular endothelial growth factor (VEGF) plays a key role in the induction CNV. Recent evidence indicates that overexpression of VEGF in the retinal pigment epithelium may lead to the development of CNV in experimental models, and intravitreal injection of a VEGF blocker prevents the development of experimental CNV. This hypothesis is also supported by the promising effects of anti-VEGF treatment in patients with choroidal neovascularisation. The substances currently in clinical use include ranibizumab (Lucentis®), bevacizumab (Avastin®) and pegaptanib (Macugen®). However, from a physiological point of view, VEGF also serves as a survival factor for existing vessels and for neuronal cells. Moreover, it has been reported that VEGF induces vasodilatation, most probably by an increased production of nitric oxide. Accordingly one may hypothesize that anti-VEGF treatment is associated with ocular vasoconstriction with unknown long term results. Thus, in the current study, the investigators set out to investigate whether the ocular perfusion is affected by a single intravitreal anti-VEGF.

Conditions

Macular Degeneration; Regional Blood Flow; Vascular Endothelial Growth Factor

Keywords

Age-related macular degeneration; anti-VEGF

Outcome Measures

Primary Outcomes (1)

• Optic nerve head blood flow

  before, one week after and three weeks after intravitreal injection with an anti-VEGF drug

Secondary Outcomes (4)

• Choroidal blood flow

  before, one week after and three weeks after intravitreal injection with an anti-VEGF drug

• Retrobulbar blood flow

  before, one week after and three weeks after intravitreal injection with an anti-VEGF drug

• Intraocular pressure

  before, one week after and three weeks after intravitreal injection with an anti-VEGF drug

• Systemic blood pressure

  before, one week after and three weeks after intravitreal injection with an anti-VEGF drug

Study Arms (1)

1

EXPERIMENTAL

patients with age-related macular degeneration, which are already scheduled for intravitreal anti-VEGF therapy in one eye are measured before and after treatment.

Drug: ranibizumab, bevacizumab or pegaptanib

Interventions

ranibizumab, bevacizumab or pegaptanib DRUG

measurements are performed one week before and after anti-VEGF intravitreal injection

1

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• subjects ≥ 50 years of age
• Subjects with all angiographic subtypes of neovascular wet AMD, already scheduled for intravitreal anti-VEGF therapy in one eye
• Good central or eccentric fixation

You may not qualify if:

• History or previous Anti-VEGF therapy
• History or previous intravitreal injection with any drug
• Intraocular pressure ≥ 25
• Glaucoma
• History or presence of thromboembolic events
• Diabetes mellitus
• Blood donation during the previous 3 weeks
• Ametropy ≥ 6 dpt

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Department of Clinical Pharmacology, Medical University of Vienna

Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Macular Degeneration

Interventions

Ranibizumab; Bevacizumab; pegaptanib

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Gerhard Garhöfer, MD

  Depatement of Clinical Pharmacology, Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof. Priv. - Doz. Dr

Study Record Dates

• First Submitted: July 1, 2008
• First Posted: July 3, 2008
• Study Start: March 1, 2008
• Primary Completion: July 1, 2010
• Study Completion: November 1, 2011
• Last Updated: November 14, 2014

Record last verified: 2014-11

Locations

AU (1)