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 |
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.
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
98-1079 Moanalua Road
'Aiea, Hawaii 96701
'Aiea, Hawaii 96701
Principal Investigator: Gregg Kokame, MD
Phone: 808-380-8060
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6320 West 159th Street
Oak Forest, Illinois 60452
Oak Forest, Illinois 60452
Principal Investigator: Rama Jager, M.D.
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