Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT02586727 |
Other study ID # |
LCH-1-012015 |
Secondary ID |
|
Status |
Completed |
Phase |
Phase 2
|
First received |
|
Last updated |
|
Start date |
October 2015 |
Est. completion date |
August 2020 |
Study information
Verified date |
October 2023 |
Source |
Larkin Community Hospital |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
The primary objective of the study is to assess the safety of intravitreal aflibercept
injection in treating visually compromising radiation maculopathy secondary to treatment of
uveal melanoma by iodione-125 brachytherapy. The study will consist of two arms of 25
patients each (totaling 50 patients). Subjects in arm 1 will undergo treatment every 6 weeks.
Subjects in arm 2 will undergo treatment and if improvement is documented at the following
evaluation the next treatment will be extended by two weeks. Secondary objectives of the
study include evaluation and analysis of visual acuity, number of injections, macular edema,
and vascular activity between both arms.
Description:
This study will consist of 2 simultaneous treatment arms: A six week dosing regimen arm and a
treat and extend (TAE) dosing regimen arm, total duration 54 weeks. In the TAE arm the
patients will receive an intravitreal aflibercept injection first visit, again at the second
visit at 6 weeks, and then begin treat and extend from second injection forward. Treatment
will be given at each visit. Patients with improved radiation maculopathy (SD-OCT analysis)
will extend re-evaluation by two weeks (e.g. first interval 6 weeks; second interval 10
weeks; third interval 12 weeks, etc). Patients with increased radiation maculopathy (SD-OCT
analysis) will have re-evaluation decreased by one week. Both arms will consist of 25
subjects (eyes). Fluorescein angiography will be completed at baseline, after the 4th
injection (or within three weeks of week 24 for the TAE arm), and at the end of the study in
all patients. Spectral domain OCT, and clinical evaluation including visual acuity will be
assessed every visit in all patients. Radiation maculopathy will be graded every visit in all
patients in a blinded fashion using the following classification system: Grade 1 indicates
extrafoveal, noncystoid edema; grade 2, extrafoveal cystoid edema; grade 3, foveal noncystoid
edema; grade 4, mild-to-moderate foveal cystoid edema; grade 5, severe foveal cystoid edema
and grade 6 subretinal fluid. All patients will undergo comprehensive evaluation including
adverse event questioning at each study timepoint. Patients in the six-week dosing arm will
receive a total of 9 intravitreal aflibercept injections during the study window while the
TAE treatment group will receive a maximum of 9 with a minimum of 5.