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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02474225
Other study ID # EC-56-168-02-4-2
Secondary ID
Status Completed
Phase N/A
First received June 11, 2015
Last updated June 16, 2015
Start date December 2013
Est. completion date May 2015

Study information

Verified date June 2015
Source Prince of Songkla University
Contact n/a
Is FDA regulated No
Health authority Thailand: Institutional Review Board
Study type Observational

Clinical Trial 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.


Description:

Intravitreal injections of anti-vascular endothelial growth factor agents are commonly used to treat a variety of retinal and choroidal neovascular diseases. The introduction of additional fluid into the vitreous cavity by intravitreal therapy would be expected to cause an immediate rise in the intraocular pressure.

Although there is one study showed no significant changes in the intraocular pressure many retrospective studies showed the impacts on the intraocular pressure elevation. The investigators aim to prospective evaluate the intraocular pressure change in non-glaucomatous patients receiving an intravitreal anti-vascular endothelial growth factor therapy.


Recruitment information / eligibility

Status Completed
Enrollment 70
Est. completion date May 2015
Est. primary completion date May 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Drug:
Intravitreal injection (bevacizumab or ranibizumab)
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)

Locations

Country Name City State
Thailand Weerawat Kiddee Hatyai Songkhla

Sponsors (1)

Lead Sponsor Collaborator
Prince of Songkla University

Country where clinical trial is conducted

Thailand, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from baseline in intraocular pressure intraocular pressure change at 6-month after injection 6-month after injection Yes
Secondary Number of anti-glaucoma used Start anti-glaucoma If there is an increase in intraocular pressure over the target IOP 6-month No
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