Open Angle Glaucoma Clinical Trial
Official title:
A Single-center, Open Label, Prospective Study Assessing the IOP (Intraocular Pressure) Patterns Using SENSIMED Triggerfish® in Association With Anti-VEGF Injection
This is a prospective, open label study assessing the 24-hour IOP patterns using TF in
patients undergoing anti-VEGF injection for the treatment of neovascular AMD (age related
macular degeneration). The study will be proposed to patients with AMD and patients with AMD
and concomitant open angle glaucoma (OAG).
The study will be conducted in two stages. In both stages, patients will remain ambulatory
and will be encouraged to follow a schedule as close to their usual lifestyle as possible,
with the exception of particular activities such as caffeine intake, playing wind
instruments, yoga and strenuous exercise. A patient diary will be distributed for the
capture of patient activities during the TF pattern recording. Upon completion of each
session, the CLS (contact lens sensor) will be removed and a final ophthalmic examination
will be conducted.
In the first stage of the study, 20 patients with neovascular AMD with an IOP in the normal
range and no concomitant glaucoma will be recruited. After having signed and dated the
patient informed consent form, patients will undergo an initial ophthalmic examination. One
eye will be selected for the study. If both eyes are eligible, the study eye will be
selected in random manner.
All 20 AMD patients will receive two 24-hour recording sessions (S) with the TF CLS, at
monthly interval. In the first session (S1) anti-VEGF injection will be carried out
according to the study center standard protocol. For the second 24-hour TF recording session
(S2), patients will be randomly distributed into three groups. Group A, consisting of 5
patients, will receive anti-VEGF injection with a different anti-VEGF substance as compared
to S1. Group B, also consisting of 5 patients, will receive anti-VEGF without sclerotomy
occlusion after injection as compared to S1. Finally, group C, including 10 patients, will
receive anti-VEGF in a different dose (injection volume) as compared to S1. The
randomization ratio between groups A, B and C is 1:1:2.
The overall study duration for an eligible patient in the first stage of this study is
limited to 5 weeks.
If in the first stage of this study an injection protocol is identified that provokes
significantly lesser elevation on the TF pattern, the alternative injection protocol will be
evaluated against the current standard protocol. For the second stage, 30 patients of whom
15 with neovascular AMD and 15 with neovascular AMD and concomitant OAG will be recruited.
After giving informed consent and confirmation of eligibility, all patients will receive two
24-hour TF CLS recording sessions (S3 and S4) at monthly interval, during which anti-VEGF
injection according to the standard and alternative protocol will be carried out in random
sequence.
The overall study duration for a patient in the second stage of the study is limited to 5
weeks.
The study has been planned to recruit 20 eligible patients in the first stage within 12
weeks from the date of initiation. The second stage will recruit 30 patients within 16
weeks. Hence the overall study duration from the first patient accrued into the study until
last patient out equates to about 33 weeks. Allowing for a database lock within 4 weeks of
study completion, a preliminary statistical report on the primary efficacy endpoint is
foreseen within 2 weeks thereafter.
n/a
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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