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) - Full Text View

Purpose

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	Intervention
Wet Age-related Macular Degeneration Age-related Macular Degeneration AMD Wet AMD Macular Degeneration	Device: IRay

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

Genetics Home Reference related topics: age-related macular degeneration X-linked juvenile retinoschisis

MedlinePlus related topics: Macular Degeneration

U.S. FDA Resources

Further study details as provided by Oraya Therapeutics, Inc.:

Primary Outcome Measures:

Number of Lucentis injections during first 52 weeks [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in mean VA [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
Loss/gain of letters of BCVA [ Time Frame: week 52 ] [ Designated as safety issue: No ]

Enrollment:	0
Study Start Date:	June 2011
Estimated Study Completion Date:	October 2014
Estimated Primary Completion Date:	October 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 24 Gy radiation	Device: IRay low voltage external beam radiosurgery
Sham Comparator: Sham 24 Gy radiation	Device: IRay low voltage external beam radiosurgery

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.

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT01339949

Locations

Italy
Università Vita-Salute Istituto Scientifico San Raffaele
Milan, Italy
United Kingdom
King's College Hospital
London, United Kingdom
Manchester Royal Eye Hospital
Manchester, United Kingdom

Sponsors and Collaborators

Oraya Therapeutics, Inc.

More Information

No publications provided

Responsible Party:	Denis O'Shaughnessy, PhD / VP, Clinical Affairs, Oraya Therapeutics, Inc
ClinicalTrials.gov Identifier:	NCT01339949 History of Changes
Other Study ID Numbers:	CLH005
Study First Received:	April 20, 2011
Last Updated:	December 28, 2011
Health Authority:	Italy: Comitato Etico Fondazione Centro S. Raffaele del Monte Tabor UK: Yorkshire and the Humber - Sheffield Research Ethics Committee

Keywords provided by Oraya Therapeutics, Inc.:

Macular Degeneration
wet Age-related Macular Degeneration
Age-Related Macular Degeneration
AMD
wet AMD
IRay
radiation

Oraya
Oraya Therapeutics, Inc
Low-voltage stereotactic radiosurgery
radiosurgery
x-ray
Lucentis
external beam radiation

Additional relevant MeSH terms:

Macular Degeneration
Choroidal Neovascularization
Retinal Degeneration
Retinal Diseases
Eye Diseases

Choroid Diseases
Uveal Diseases
Neovascularization, Pathologic
Metaplasia
Pathologic Processes

ClinicalTrials.gov processed this record on May 19, 2013