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

NCT01521065 | Unknown Phase 2 DMC

• 1 other identifier: RS002
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Keywords

AMD; Wet AMD

Outcome Measures

Primary Outcomes (1)

• Rate of anti-VEGF injections during the first 12 months

  12 Months

Secondary Outcomes (3)

• Time to first Anti-VEGF injection

  Up to Month 12

• Change in mean best-corrected visual acuity in the treated eye at month 12

  Month 12

• Visual Functioning Questionnaire - 25 (VFQ-25)

  Baseline & Month 12

Study Arms (1)

16 Gy IRay

EXPERIMENTAL

16 Gy IRay + PRN Lucentis®

Device: IRay

Interventions

IRay 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.

16 Gy IRay

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Oraya Therapeutics, Inc.: lead

Study Sites (1)

Manchester Royal Eye Hospital

Manchester, M13 9WL, United Kingdom

RECRUITING

MeSH Terms

Conditions

Macular Degeneration; Wet Macular Degeneration; Eye Diseases; Retinal Diseases

Condition Hierarchy (Ancestors)

Retinal Degeneration

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2012
• First Posted: January 30, 2012
• Study Start: September 1, 2012
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2016
• Last Updated: April 26, 2013

Record last verified: 2013-04

Locations

GB (1)