Clinical Trial Details
— Status: Terminated
Administrative data
NCT number |
NCT01994174 |
Other study ID # |
0583-13-FB |
Secondary ID |
|
Status |
Terminated |
Phase |
|
First received |
|
Last updated |
|
Start date |
December 20, 2013 |
Est. completion date |
January 12, 2023 |
Study information
Verified date |
October 2023 |
Source |
University of Nebraska |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational [Patient Registry]
|
Clinical Trial 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.
Description:
Intravitreal injection of different anti-VEGF agents such as bevacizumab (Avastin, Genentech,
Inc., South San Francisco, CA, USA) ranibizumab (Lucentis; Genentech, Inc., South San
Francisco, CA, USA) and aflibercept (Eylea, Regeneron, Tarrytown, NY, USA) has been a widely
common practice for treatment of choroidal neovascularization and retinal vascular diseases
[1]. Several ocular and systemic adverse events have been reported with the use of anti-VEGF
agents [7]. Elevation of intraocular pressure (IOP) is a serious ocular adverse event that
may be associated with intravitreal injection of anti-VEGF agents. IOP elevation with
anti-VEGF injection may have variable presentation ranging from acute transient post
injection elevation to the development of persistent IOP elevation that mandates pressure
lowering therapy[8].
Patients with previously existing glaucoma may have a higher rate of persistent IOP elevation
associated with intravitreal injection of anti-VEGF agents. Good et al, reported the rate of
persistent IOP elevation after intravitreal anti-VEGF to be 33% in glaucoma patients versus
3.1% in eyes without previous diagnosis of glaucoma [9]. Tseng et al, reported 25 eyes with
sustained elevation of IOP after serial intravitreal injections of anti-VEGF agents (mean =
20injections). All the 25 eyes were normotensive prior to the study and 23 of them were not
previously diagnosed with glaucoma[10].
Multicenter clinical trials that studied the intravitreal injection of anti-VEGF agents, such
as MARINA and ANCHOR for ranibizumab, VISION for pegaptanib and PACORES for bevacizumab, did
not show sustained IOP elevation with the intravitreal injection of the study agents [12-15].
However, a subgroup analysis of the data of MARINA and ANCHOR trials showed at least 6 mm Hg
increase of IOP from baseline in 2.1% of eyes in MARINA trial and 3.6% of eyes in ANCHOR
trial [16]. A retrospective chart review of 207 patients over a 6-months follow up period
after serial intravitreal injections of anti-VEGF reported an IOP elevation greater than 5 mm
Hg in 2 consecutive visits compared to baseline in 11.6% of the treated eyes versus 5.3% in
control eyes [17].
The pathophysiology of the reported IOP elevation associated with intravitreal injection of
anti-VEGF is unknown. Anti-VEGF compounds might increase aqueous humor inflow by the
breakdown of the blood-aqueous barrier or reduce uveoscleral outflow by the ciliary body
vasculature. These potential changes could translate into elevated IOP and glaucoma.