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)

December 28, 2011 updated by: Oraya Therapeutics, Inc.

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Not Applicable

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

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

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:

  1. 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.
  2. Subjects must now have the need for further anti-VEGF treatment due to increased fluid or persistent cysts on OCT, or leakage on FA.
  3. 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.
  4. 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.
  5. Subjects must be at least 50 years of age.
  6. 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.
  7. 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:

  1. CNV due to causes other than AMD, including ocular histoplasmosis syndrome, angioid streaks, multifocal choroiditis, choroidal rupture, or pathologic myopia (spherical equivalent ≥-8 diopters).
  2. A globe axial length of <20 mm or >26 mm.
  3. Evidence of uncontrolled diabetes as determined by an HbA1c of >6.5% and/or with retinal findings consistent with diabetic retinopathy.
  4. 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.
  5. History of radiation to the head in the region of 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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Lucentis injections during first 52 weeks
Time Frame: 52 weeks
52 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in mean VA
Time Frame: 52 weeks
52 weeks
Loss/gain of letters of BCVA
Time Frame: week 52
week 52

Collaborators and Investigators

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

Sponsor

Oraya Therapeutics, Inc.

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

June 1, 2011

Primary Completion (Anticipated)

October 1, 2012

Study Completion (Anticipated)

October 1, 2014

Study Registration Dates

First Submitted

April 20, 2011

First Submitted That Met QC Criteria

April 20, 2011

First Posted (Estimate)

April 21, 2011

Study Record Updates

Last Update Posted (Estimate)

December 30, 2011

Last Update Submitted That Met QC Criteria

December 28, 2011

Last Verified

December 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLH005

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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