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Study to Evaluate the Safety and Effectiveness of IRay in Wet Age-related Macular Degeneration (AMD) Patients With Recurrent Leakage Secondary to Choroidal Neovascularisation (CNV)

NCT ID: NCT01339949

Last Updated: 2011-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2014-10-31

Brief Summary

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The objective of this study is to confirm the safety and to establish the effectiveness of low voltage external beam radiosurgery using the IRay System for the treatment of subjects with recurrent leakage secondary to neovascular Age-related Macular Degeneration (AMD) as determined by decreasing the number of Lucentis injections required during the first 12 months of the study.

Detailed Description

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The objective of this study is to confirm the safety and to establish the effectiveness of low voltage external beam radiosurgery using the IRay System for the treatment of subjects with recurrent leakage secondary to neovascular AMD as determined by decreasing the number of Lucentis injections required during the first 12 months of the study.

Conditions

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Wet Age-related Macular Degeneration Age-related Macular Degeneration AMD Wet AMD Macular Degeneration

Keywords

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AMD wet AMD Macular Degeneration wet Age-related Macular Degeneration Age-Related Macular Degeneration IRay radiation Oraya Oraya Therapeutics, Inc Low-voltage stereotactic radiosurgery radiosurgery x-ray Lucentis external beam radiation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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24 Gy radiation

Group Type EXPERIMENTAL

IRay

Intervention Type DEVICE

low voltage external beam radiosurgery

Sham 24 Gy radiation

Group Type SHAM_COMPARATOR

IRay

Intervention Type DEVICE

low voltage external beam radiosurgery

Interventions

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IRay

low voltage external beam radiosurgery

Intervention Type DEVICE

IRay

low voltage external beam radiosurgery

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Subjects must have neovascular AMD, have received at least 6 prior injections with Lucentis or Avastin and have exhibited one or more of the following:

* have persisting fluid despite 3 consecutive monthly injections of anti- VEGF, or
* received 4 prior injections over a 6 month period, or
* received 8 prior injections over a 12 month period.
2. Subjects must now have the need for further anti-VEGF treatment due to increased fluid or persistent cysts on OCT, or leakage on FA.
3. Subjects must have a total lesion size of ≤12 disc areas and a CNV 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.
4. Subjects must have signed (and been given) a copy of the informed consent form, and be willing and able to return for scheduled treatment and follow-up examinations for the 3-year duration of the study.
5. Subjects must be at least 50 years of age.
6. 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.
7. Subjects must have best corrected visual acuity of 75 to 25 letters in the study eye and at least 20 letters in the fellow eye.

Exclusion Criteria

1. CNV due to causes other than AMD, including ocular histoplasmosis syndrome, angioid streaks, multifocal choroiditis, choroidal rupture, or pathologic myopia (spherical equivalent ≥-8 diopters).
2. A globe axial length of \<20 mm or \>26 mm.
3. Evidence of uncontrolled diabetes as determined by an HbA1c of \>6.5% and/or with retinal findings consistent with diabetic retinopathy.
4. Prior or concurrent therapies for age related macular degeneration including submacular surgery, subfoveal thermal laser photocoagulation (with or without photographic evidence), transpupillary thermotherapy (TTT), or ocular photodynamic therapy in the study eye.
5. History of radiation to the head in the region of the study eye.
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Oraya Therapeutics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Oraya Therapeutics, Inc

Locations

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Università Vita-Salute Istituto Scientifico San Raffaele

Milan, , Italy

Site Status

King's College Hospital

London, , United Kingdom

Site Status

Manchester Royal Eye Hospital

Manchester, , United Kingdom

Site Status

Countries

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Italy United Kingdom

Other Identifiers

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CLH005

Identifier Type: -

Identifier Source: org_study_id