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 (ENDEAVOUR)
Verified April 2013 by Oraya Therapeutics, Inc.
Information provided by (Responsible Party):
Oraya Therapeutics, Inc.
First received: January 18, 2012
Last updated: April 24, 2013
Last verified: April 2013
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).
Age-Related Macular Degeneration
Wet Macular Degeneration
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||A Multicenter, Open-label Study to Evaluate the Clinical and Economic Benefits of Low Voltage Stereotactic Radiotherapy in Subjects With Choroidal Neovascularization (CNV) Secondary to Age-related Macular Degeneration (AMD)
Primary Outcome Measures:
- Rate of anti-VEGF injections during the first 12 months [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Time to first Anti-VEGF injection [ Time Frame: Up to Month 12 ] [ Designated as safety issue: No ]
- Change in mean best-corrected visual acuity in the treated eye at month 12 [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
- Visual Functioning Questionnaire - 25 (VFQ-25) [ Time Frame: Baseline & Month 12 ] [ Designated as safety issue: No ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||October 2014 (Final data collection date for primary outcome measure)
Experimental: 16 Gy IRay
16 Gy IRay + PRN Lucentis®
Approved dose of Anti-VEGF injection given at Day 0 followed by treatment with 16 Gy dose of IRay up to 14 days later.
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.
|Ages Eligible for Study:
||50 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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).
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01521065
|Manchester Royal Eye Hospital
|Manchester, United Kingdom, M13 9WL |
|Contact: Tariq Aslam, M.D. +44 771 125 0512 firstname.lastname@example.org |
|Principal Investigator: Tariq Aslam, M.D. |
Oraya Therapeutics, Inc.
No publications provided
||Oraya Therapeutics, Inc.
History of Changes
|Other Study ID Numbers:
|Study First Received:
||January 18, 2012
||April 24, 2013
||United Kingdom: Research Ethics Committee
Keywords provided by Oraya Therapeutics, Inc.:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 01, 2015
Wet Macular Degeneration