Safety & Tolerability of the IRay System in Subjects With Exudative Choroidal Neovascularization (CNV) Secondary to Age-Related Macular Degeneration (AMD)

January 18, 2012 updated by: Oraya Therapeutics, Inc.

A Pilot Study to Evaluate the Safety and Tolerability of the IRay Stereotactic Radiosurgery System in Subjects With Exudative Choroidal Neovascularization (CNV) Secondary to Age-Related Macular Degeneration (AMD)

The purpose of this study is to evaluate the safety and clinical feasibility of the IRay System for the treatment of wet age-related macular degeneration (AMD).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The primary objective is to evaluate the safety and clinical feasibility of stereotactic radiotherapy with the Oraya IRay system for the treatment of choroidal neovascularization (CNV) associated with age-related macular degeneration (AMD), as measured by incidence and severity of ocular radiation related serious adverse events (SAE) and adverse events (AE) in subjects treated with an 11, 16 or 24 Gray (Gy) macular dose through the 60-month follow-up visit.

Study Type

Interventional

Enrollment (Actual)

62

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Delegación Coyoacán
      • Mexico Distrito Federal, Delegación Coyoacán, Mexico, 04030
        • Asociación para Evitar la Ceguera en México, I.A.P.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects must be age 50 or older
  • Women must be post-menopausal ≥1 year or surgically sterilized
  • Subjects must have choroidal neovascularization lesion size of ≤11 total disc areas (28.26mm), and a greatest linear dimension of ≤6 mm
  • Subjects must have Early Treatment Diabetic Retinopathy Study (ETDRS) best corrected visual acuity of 69 to 24 letters (20/40 to 20/320 Snellen Equivalent) in the study eye
  • Subretinal hemorrhage (if any) must not comprise more than 50% of total lesion size, and may not involve the subfoveal space

Exclusion Criteria:

  • Subjects with prior or concurrent therapies including submacular surgery, thermal laser photocoagulation (with or without photographic evidence), photodynamic therapy and transpupillary thermotherapy (TTT)
  • Subjects with concomitant disease in the study eye, including uveitis, diabetic retinopathy,presence of RPE tears or rips, acute ocular or periocular infection
  • Subjects with advanced glaucoma (>0.8 cup to disk ratio) or intraocular pressure ≥30 mmHg in the study eye
  • Previous glaucoma filtering surgery in the study eye
  • Refractive error in the study eye demonstrating more than -8 diopters of myopia (or globe axial length ≥26 mm). For subjects who have undergone prior refractive or cataract surgery in the study eye, the preoperative refractive error cannot exceed -8 diopters of myopia
  • Subjects with any retinal vasculopathies, including diabetic retinopathy, retinal vein occlusions, etc. in the study eye

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 11 Gy IRay
Day 0 Lucentis followed by 11 Gy IRay, Lucentis at Month 1 and Lucentis PRN (N = 2)
Device: IRay
Low voltage stereotactic radiotherapy system
EXPERIMENTAL: 16 Gy IRay
Day 0 Lucentis followed by 16 Gy IRay, Lucentis at Month 1 and Lucentis PRN (N = 27)
Device: IRay
Low voltage stereotactic radiotherapy system
EXPERIMENTAL: 16 Gy IRay - Radiation First
16 Gy IRay and Lucentis PRN (N = 13)
Device: IRay
Low voltage stereotactic radiotherapy system
EXPERIMENTAL: 24 Gy IRay
Day 0 Lucentis followed by 24 Gy IRay, Lucentis at Month 1 and Lucentis PRN (N = 19)
Device: IRay
Low voltage stereotactic radiotherapy system

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of ocular radiation-related adverse events
Time Frame: Month 12
Month 12

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of ocular adverse events
Time Frame: Through month 60
Through month 60
Percentage of subjects who lose at least 15 Early Treatment Diabetic Retinopathy Study (ETDRS) letters in best corrected visual acuity (BCVA)
Time Frame: Month 12
Month 12
Percentage of subjects gaining ≥ 15 ETDRS letters
Time Frame: Month 12
Month 12
Percentage of subjects gaining ≥ 0 ETDRS letters
Time Frame: Month 12
Month 12
Mean change in ETDRS visual acuity
Time Frame: Month 12
Month 12
Mean time to anti-VEGF retreatment following 2nd mandatory injection (excluding radiation-first subjects)
Time Frame: Month 12
Month 12
Mean total number of ranibizumab injections
Time Frame: Through month 12 and 24
Through month 12 and 24
Change in choroidal neovascularization (CNV) size by fluorescein angiography (FA)
Time Frame: Month 12
Month 12
Change in total lesion size by fluorescein angiography (FA)
Time Frame: Month 12
Month 12
Change in central retinal lesion thickness by optical coherence tomography (OCT)
Time Frame: Month 12
Month 12
Change in central subfield thickness by optical coherence tomography (OCT)
Time Frame: Month 12
Month 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oraya Therapeutics, Inc.

Investigators

  • Study Director: Denis O'Shaughnessy, Ph.D., Oraya Therapeutics, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (ACTUAL)

October 1, 2010

Study Completion (ANTICIPATED)

October 1, 2014

Study Registration Dates

First Submitted

October 5, 2010

First Submitted That Met QC Criteria

October 7, 2010

First Posted (ESTIMATE)

October 8, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

January 19, 2012

Last Update Submitted That Met QC Criteria

January 18, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLH001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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