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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01521065
Other study ID # RS002
Secondary ID
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


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
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