A Pilot, Single-center, Interventional Clinical Trial in Which Subjects With Polypoidal Choroidal Vasculopathy (PCV) Secondary to Age-Related Macular Degeneration (AMD) Will Receive Low Voltage Stereotactic Radiotherapy (IRay®) Treatment and Lucentis® Treatment as Needed.

Oraya Therapeutics, Inc.1 site in 1 country12 target enrollmentJanuary 2012

ConditionsPolypoidal Chorodial Vasculopathy Age Related Macular Degeneration

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Polypoidal Chorodial Vasculopathy
Sponsor: Oraya Therapeutics, Inc.
Enrollment: 12
Locations: 1
Primary Endpoint: Lesion change as measured with fluorescein angiography.
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study will evaluate the efficacy of IRay treatment in patients with Polypoidal Choroidal Vasculopathy (PCV)secondary to AMD as determined by the change in the proportion of lesion activity and lesion size at 12 months.

Detailed Description

This is a single-center, interventional clinical trial in which subjects will receive 16 Gy of IRay treatment and Lucentis, followed by Lucentis treatment as needed to evaluate the efficacy of IRay treatment in patients with PCV as determined by the change in the proportion of lesion activity and lesion size at 12 months.

Registry

clinicaltrials.gov

Start Date

January 2012

End Date

March 2014

Last Updated

13 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Oraya Therapeutics, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patients with PCV, naïve or previously treated with Lucentis injections and Photodynamic therapy (PDT) using Visudyne.
•Must have a total lesion size of \<12 disc areas and a PCV lesion with the greatest linear dimension of \<6 mm, but not greater than 3 mm from the center of the fovea to the furthest point on lesion perimeter (determined by ICG).
•The distance from the center of the fovea to the nearest edge of the optic disc should be not less than 3 mm. (This distance is confirmed by Oraya software prior to treatment.).
•Must have provided informed consent, documented it in writing, and have been given a copy of the signed informed consent form.
•Must be willing and able to return for scheduled visits for the 2-year duration of the study.
•Must be at least 50 years of age.
•Women must be post-menopausal ≥1 year or surgically sterilized, or a pregnancy screen must be performed prior to the study and a reliable form of contraception, approved by the investigator, must be maintained during the study.
•Must have best corrected visual acuity of 75 to 25 letters (inclusive) in the study eye and at least 20 letters in the fellow eye (if both eyes meet all the study criteria, then the eye with the worst vision should be selected as the study eye).

Exclusion Criteria

•CNV due to causes other than AMD or PCV, including ocular histoplasmosis syndrome, angioid streaks, multifocal choroiditis, choroidal rupture, or pathologic myopia (spherical equivalent -8 diopters).
•A globe axial length of \<20 mm or \>26 mm.
•Evidence of diabetes or with retinal findings consistent with diabetic retinopathy or retinopathy for any other cause.
•Hypertension that is not controlled with anti-hypertensive medication.
•Prior or concurrent therapies for age related macular degeneration or PCV, including submacular surgery, subfoveal thermal laser photocoagulation (with or without photographic evidence), or transpupillary thermotherapy (TTT).
•History of radiation to the head in the region of the study eye.
•Previous posterior vitrectomy at any time, YAG capsulotomy or cataract surgery within 3 months, or any other surgery in the study eye within 6 months prior to the screening visit.
•Intravitreal device in the study eye.
•Concomitant disease in the study eye which might interfere with the effect of assessment of the study treatment, including uveitis, acute ocular or periocular infection, retinal vasculopathies (including retinal vein occlusions, etc.) or intraocular pressure \>30 mmHg uncontrollable with medications.
•History of rhegmatogenous retina detachment, optic neuritis or intraocular tumors in the study eye.