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

Age-Related Macular Degeneration Clinical Trial

— ENDEAVOUR  

Official title:

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01521065
• Other study ID #: RS002
• Status: Recruiting
• Phase: Phase 2
• First received: January 18, 2012
• Last updated: April 24, 2013
• Start date: September 2012
• Est. completion date: October 2016

Study information

• Verified date: April 2013
• Source: Oraya Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: October 2016
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Age-Related Macular Degeneration
• Choroidal Neovascularization
• Eye Diseases
• Macular Degeneration
• Neovascularization, Pathologic
• Retinal Diseases
• Wet Macular Degeneration

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United Kingdom	Manchester Royal Eye Hospital	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
Oraya Therapeutics, Inc.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of anti-VEGF injections during the first 12 months		12 Months	No
Secondary	Time to first Anti-VEGF injection		Up to Month 12	No
Secondary	Change in mean best-corrected visual acuity in the treated eye at month 12		Month 12	No
Secondary	Visual Functioning Questionnaire - 25 (VFQ-25)		Baseline & Month 12	No

External Links

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