Effect of Vascular Endothelial Growth Factor Blockers on Aqueous Humor Dynamics

NCT01994174 | Terminated

• 1 other identifier: 0583-13-FB
• Study Type: observational
• Target: 13
• Locations: 1 country
• Sites: 2

Brief Summary

The objective of this research is to determine the effects of anti-VEGF drugs (bevacizumab, ranibizumab or aflibercept) on aqueous humor dynamics (AHD) in patients with retinal vascular disease. The underlying hypothesis is that anti-VEGF drugs increase intraocular pressure (IOP) by increasing aqueous inflow, decreasing uveoscleral outflow or both. The specific aim is to evaluate the changes produced in AHD after 1 baseline and a subsequent 1 monthly injection of anti VEGF agents.

Conditions

Macular Disease

Keywords

vascular; retina; Anti-VEGF; Aqueous humor dynamics

Outcome Measures

Primary Outcomes (1)

• Uveoscleral outflow changes

  The uveoscleral outflow changes will be assess at baseline prior to any anti-VEGF treatment and after the 3rd intravitreal treatment has been done.

  1-2 months

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with established diagnosis of retinal vascular diseases (diabetic macular edema, neovascular macular degeneration, presumed ocular histoplasmosis syndrome, high myopia) who require intravitreal injection of anti-VEGF drugs such as bevacizumab, ranibizumab or aflibercept and are likely to need three monthly doses.

You may qualify if:

• Subjects must be at least 19 years of age and older
• Ability to give informed consent and attend the study visits
• Patients with established diagnosis of retinal vascular diseases (diabetic macular edema, neovascular macular degeneration,presumed ocular histoplasmosis syndrome, high myopia) who require intravitreal injection of anti-VEGF drugs such as bevacizumab,ranibizumab or aflibercept and are likely to need three monthly doses.
• Patients who have not received intravitreal injections within 3 months of study entry
• No previous established diagnosis of glaucoma and consequently no previous history of Argon Laser Trabeculoplasty (ALT) or Selective Laser Trabeculoplasty (SLT).
• No previous history of ocular surgery
• Patients who are not planning on and are unlikely to require an elective ocular surgical or laser procedure within the study duration
• Open angle of the anterior chamber on clinical examination
• Ability to cooperate for aqueous humor dynamic studies
• Contact lenses removed prior to topical fluorescein instillation, and not used until the end of each fluorophotometry session
• Able to participate on site over the multi-visit study period

You may not qualify if:

• Age less than 18 years of age
• Women who are pregnant or nursing
• Ocular hypertension or glaucoma
• Narrow angle with complete or partial closure (gonioscopy angle \<2)
• Any previous surgical or laser procedures
• Secondary glaucoma including pigmentary, exfoliative, uveitic and traumatic glaucomas
• Any active neovascularization of the iris, angle, disc or retina
• Diagnosis of retinal arterial or vein occlusion
• Chronic or recurrent inflammatory eye disease
• Ocular trauma within the past 6 months
• Ocular infection or ocular inflammation in the past 2 months
• Any abnormality preventing reliable fluorophotometry of either eye,such as corneal scarring or severe dry eye that results in punctuate fluorescein staining of the cornea
• Intraocular surgery within 6 months
• Serious hypersensitivity to any components of the study medications or risk from treatment with glaucoma medications, such as severe asthma or emphysema.
• Use of any glucocorticoid by any route. Subject must be washed out of the glucocorticoid for at least 2 weeks before study entry.

Sponsors & Collaborators

• University of Nebraska: lead

Study Sites (2)

University of Nebraska Medical Center, Truhlsen Eye Institute

Omaha, Nebraska, 68105, United States

Location

University of Nebraska Medical Center, Department of Ophthalmology and Visual Sciences

Omaha, Nebraska, 68198-5540, United States

Location

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Officials

• Vikas Gulati, MD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Weeks
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2013
• First Posted: November 25, 2013
• Study Start: December 20, 2013
• Primary Completion: January 12, 2023
• Study Completion: January 12, 2023
• Last Updated: October 6, 2023

Record last verified: 2023-10

Locations

US (2)