Episcleral Brachytherapy for the Treatment of Wet AMD



Status:Active, not recruiting
Conditions:Cardiology, Ocular
Therapuetic Areas:Cardiology / Vascular Diseases, Ophthalmology
Healthy:No
Age Range:50 - Any
Updated:10/5/2018
Start Date:August 1, 2017
End Date:January 2020

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A Prospective Study of Episcleral Brachytherapy for the Treatment of Neovascular Age-related Macular Degeneration

This is a prospective, single-arm, open-label, safety, usability and tolerability trial of
Strontium 90 (Sr90) beta radiation episcleral brachytherapy in subjects receiving anti-VEGF
therapy pro re nata (PRN) for the treatment of early neovascular Age-related Macular
Degeneration (nAMD) lesions. Secondary aims are to observe clinical outcomes of area of
leakage, sub-retinal fluid, lesion size, visual acuity, and anti-vascular endothelial growth
factor (anti-VEGF) treatment burden.

Subjects will receive a single brachytherapy treatment and 52-weeks of follow-up.

Inclusion Criteria:

- Diagnosis of CNV or PCV due to nAMD by angiography

- Male or female aged 50 years or older

- Documentation of prior treatment for nAMD

- Patients must have demonstrated clinical or OCT/angiographic evidence that, in the
investigator's opinion, requires treatment with anti-VEGF therapy.

- BCVA 20/40 - 20/200 Snellen equivalent in study eye

- Actively leaking neovascular complex as determined by angiography

- Ability to understand nature/purpose of trial and to provide informed consent

- Ability to undergo diagnostic tests and surgical interventions

- Ability to follow instructions and complete the trial including all scheduled visits
and follow-up

Exclusion Criteria:

- Women who are pregnant or plan to become pregnant during the study

- CNV other than due to nAMD

- Sub-foveal lesion hemorrhage obscuring >50% of lesion

- CNV lesion with greatest linear dimension >3750 microns as determined by angiography

- Presence of subretinal fibrosis or retinal pigment epithelial atrophy involving the
central macula in the study eye

- Existing Retinal Pigment Epithelial tear

- Previous treatment (excluding vitamins) for nAMD in the study eye other than anti-VEGF
therapy in the last 6 months

- A change in anti-VEGF agent in the previous two administrations

- Anticipate a change to the anti-VEGF agent during the conduct of the study

- Previous intraocular surgery in study eye other than for uncomplicated
phacoemulsification cataract extraction

- Other clinically significant ocular co-morbidity including, but not limited to, optic
glaucoma, optic neuropathy of any cause, maculopathy / retinopathy of any cause other
than nAMD, and scleritis

- History of refractive error of - 6D or greater (spherical equivalent) or demonstrated
myopic degeneration

- Media opacity sufficient to preclude adequate fundoscopy, OCT or angiography

- Uncontrolled systemic diseases (e.g. controlled hypertension is acceptable)

- Type I or type II diabetes mellitus

- Clinically significant previous radiation to the eye

- On anticoagulation or dual anti-platelet therapy with abnormal coagulation panel
results.

- Patient unsuitable for IV or local anesthesia

- Any contraindication to anti-VEGF, fluorescein, topical and local anesthetics, topical
antiseptics, or topical antibiotics to be used during the study

- Active ocular or periocular infection or intraocular inflammation

- Fellow eye with worse visual acuity than the study eye.

- Any condition which, in the investigators' opinion, would conflict or otherwise
prevent the subject from complying with the required procedures, schedule or other
study conduct
We found this trial at
2
sites
6320 West 159th Street
Oak Forest, Illinois 60452
Principal Investigator: Rama Jager, M.D.
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Oak Forest, IL
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98-1079 Moanalua Road
'Aiea, Hawaii 96701
Principal Investigator: Gregg Kokame, MD
Phone: 808-380-8060
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'Aiea, HI
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