Intraocular Pressure Change Following Intravitreal Injection of Anti-vascular Endothelial Growth Factor Agent

NCT02474225 | Completed

• 1 other identifier: EC-56-168-02-4-2
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

The introduction of additional fluid into the vitreous cavity by intravitreal therapy would be expected to cause an immediate rise in the intraocular pressure. This transient, short-term intraocular pressure elevation (lasting up to 30 minutes) after intravitreal anti-vascular endothelial growth factor therapy has been well describe. The investigators aim to study the prevalence of the sustained intraocular pressure elevation associated with intravitreal injection of anti-vascular endothelial growth factor agents.

Conditions

Intraocular Pressure

Keywords

intraocular pressure; intravitreal

Outcome Measures

Primary Outcomes (1)

• Change from baseline in intraocular pressure

  intraocular pressure change at 6-month after injection

  6-month after injection

Secondary Outcomes (1)

• Number of anti-glaucoma used

  6-month

Interventions

Intravitreal injection (bevacizumab or ranibizumab) DRUG

The intravitreal anti-vascular endothelial growth factor agent of 0.1 ml of bevacizumab (2.5 mg/0.1 ml) or ranibizumab (1 mg/0.1 ml)

Also known as: anti-vascular endothelial growth factor agent

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The patients scheduled to receive intravitreal injection of anti-vascular endothelial growth factor agent (either bevacizumab or ranibizumab) and were recruited.

You may qualify if:

• Patients scheduled to receive intravitreal injection of anti-vascular endothelial growth factor agent (either bevacizumab or ranibizumab), and
• Age of 18-85 year-old, and
• Initial intraocular pressure \< 21 mmHg

You may not qualify if:

• Diagnosis of open angle, or
• Diagnosis of angle-closure glaucoma, or
• Diagnosis of glaucoma suspect (intraocular pressure \> 21 mmHg on 2-consecutive visit and/or cup to disc ratio \> 0.5) , or
• Currently receive systemic beta-blocker
• Previously received intravitreal injection of anti-vascular endothelial growth factor agent
• Previously received intravitreal injection of steroid or gancyclovir
• Current use of steroid eye drop
• Any ocular surface disease preclude a reliable intraocular pressure measurement

Sponsors & Collaborators

• Prince of Songkla University: lead

Study Sites (1)

Weerawat Kiddee

Hat Yai, Changwat Songkhla, 90110, Thailand

Location

MeSH Terms

Interventions

Intravitreal Injections; Bevacizumab; Ranibizumab

Intervention Hierarchy (Ancestors)

Injections, Intraocular; Injections; Drug Administration Routes; Drug Therapy; Therapeutics; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Asst.Prof.Weerawat Kiddee, MD

  Prince of Songkla University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst. Prof.

Study Record Dates

• First Submitted: June 11, 2015
• First Posted: June 17, 2015
• Study Start: December 1, 2013
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: June 17, 2015

Record last verified: 2015-06

Locations

TH (1)