An Open-label Study to Evaluate the Clinical and Economic Benefits of I-Ray in Patients With Choroidal Neovascularization Secondary to Age-related Macular Degeneration

NCT ID: NCT01521065

Last Updated: 2013-04-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2016-10-31

Brief Summary

The purpose of this study is to confirm the clinical and economic benefits of IRay treatment with respect to the number of anti-VEGF injections and frequency of visits during the first year after treatment for patients with wet Age-related Macular Degeneration (AMD).

Detailed Description

The objective of this study is to confirm the clinical and economic benefits of low voltage external beam radiotherapy with the IRay with respect to number of anti-VEGF injections and frequency of ophthalmic assessments during the one year interval following treatment in subjects with neovascular AMD.

Conditions

Age-Related Macular Degeneration; Wet Macular Degeneration; Macular Degeneration; Eye Diseases; Retinal Diseases

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

16 Gy IRay

16 Gy IRay + PRN Lucentis®

Group Type: EXPERIMENTAL

IRay

Intervention Type: DEVICE

Approved dose of Anti-VEGF injection given at Day 0 followed by treatment with 16 Gy dose of IRay up to 14 days later.

Interventions

IRay

Approved dose of Anti-VEGF injection given at Day 0 followed by treatment with 16 Gy dose of IRay up to 14 days later.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Must have neovascular AMD and have received an anti-VEGF injections within 1 month prior to entering the study, and have the need for further treatment with anti-VEGF therapy.
• 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.
• 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 treatment and follow-up examinations for the 3-year duration of the study.
• Must be at least 50 years of age.
• Women must be post-menopausal ≥1 year or surgically sterilized.
• Must have best corrected visual acuity of greater than or equal to 24 letters 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

• Present with any implanted device, where the device labeling specifically contraindicates subjects undergoing x-rays.
• An axial length of <20 mm (because of limitations of the IRay device) or >26 mm (to exclude subjects with pathologic myopia).
• Evidence of diabetes or retinal findings consistent with diabetic retinopathy, or retinopathy for any cause.
• Prior or concurrent therapies in the study eye for age related macular degeneration (other than intravitreal anti-VEGF), including submacular surgery, subfoveal thermal laser photocoagulation (with or without photographic evidence), transpupillary thermotherapy (TTT) and ocular photodynamic therapy.

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oraya Therapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Manchester Royal Eye Hospital

Manchester, , United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Facility Contacts

Tariq Aslam, M.D.

Role: primary

tariq.aslam@cmft.nhs.uk

+44 771 125 0512

Other Identifiers

RS002

Identifier Type: -

Identifier Source: org_study_id