Study to Evaluate the Safety and Effectiveness of IRay in Wet Age-related Macular Degeneration (AMD) Patients With Recurrent Leakage Secondary to Choroidal Neovascularisation (CNV)

Sponsor

Oraya Therapeutics, Inc. (Industry)

Overall Status

Withdrawn

CT.gov ID

NCT01339949

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The objective of this study is to confirm the safety and to establish the effectiveness of low voltage external beam radiosurgery using the IRay System for the treatment of subjects with recurrent leakage secondary to neovascular Age-related Macular Degeneration (AMD) as determined by decreasing the number of Lucentis injections required during the first 12 months of the study.

Condition or Disease	Intervention/Treatment	Phase
Wet Age-related Macular Degeneration Age-related Macular Degeneration AMD Wet AMD Macular Degeneration	Device: IRay Device: IRay	N/A

Detailed Description

The objective of this study is to confirm the safety and to establish the effectiveness of low voltage external beam radiosurgery using the IRay System for the treatment of subjects with recurrent leakage secondary to neovascular AMD as determined by decreasing the number of Lucentis injections required during the first 12 months of the study.

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A Double-masked, Sham Controlled, Study to Evaluate the Safety and Effectiveness of Low Voltage Stereotactic Radiosurgery in Wet AMD Patients With Recurrent Leakage Secondary to CNV

Study Start Date :

Jun 1, 2011

Anticipated Primary Completion Date :

Oct 1, 2012

Anticipated Study Completion Date :

Oct 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 24 Gy radiation	Device: IRay low voltage external beam radiosurgery
Sham Comparator: Sham 24 Gy radiation	Device: IRay low voltage external beam radiosurgery

Arm

Intervention/Treatment

Experimental: 24 Gy radiation

Device: IRay

low voltage external beam radiosurgery

Sham Comparator: Sham 24 Gy radiation

Device: IRay

low voltage external beam radiosurgery

Outcome Measures

Primary Outcome Measures

Number of Lucentis injections during first 52 weeks [52 weeks]

Secondary Outcome Measures

Change in mean VA [52 weeks]
Loss/gain of letters of BCVA [week 52]

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Subjects must have neovascular AMD, have received at least 6 prior injections with

Lucentis or Avastin and have exhibited one or more of the following:

have persisting fluid despite 3 consecutive monthly injections of anti- VEGF, or
received 4 prior injections over a 6 month period, or
received 8 prior injections over a 12 month period.

Subjects must now have the need for further anti-VEGF treatment due to increased fluid or persistent cysts on OCT, or leakage on FA.
Subjects 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.
Subjects must have signed (and been given) a copy of the informed consent form, and be willing and able to return for scheduled treatment and follow-up examinations for the 3-year duration of the study.
Subjects must be at least 50 years of age.
Women must be post-menopausal ≥1 year or surgically sterilized, or a pregnancy screen must be performed prior to the study and a reliable form of contraception approved by the investigator must be maintained during the study.
Subjects must have best corrected visual acuity of 75 to 25 letters in the study eye and at least 20 letters in the fellow eye.

Exclusion Criteria:

CNV due to causes other than AMD, including ocular histoplasmosis syndrome, angioid streaks, multifocal choroiditis, choroidal rupture, or pathologic myopia (spherical equivalent ≥-8 diopters).
A globe axial length of <20 mm or >26 mm.
Evidence of uncontrolled diabetes as determined by an HbA1c of >6.5% and/or with retinal findings consistent with diabetic retinopathy.
Prior or concurrent therapies for age related macular degeneration including submacular surgery, subfoveal thermal laser photocoagulation (with or without photographic evidence), transpupillary thermotherapy (TTT), or ocular photodynamic therapy in the study eye.
History of radiation to the head in the region of the study eye.

Contacts and Locations

Locations

	Site	City	Country
1	Università Vita-Salute Istituto Scientifico San Raffaele	Milan	Italy
2	King's College Hospital	London	United Kingdom
3	Manchester Royal Eye Hospital	Manchester	United Kingdom