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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT01339949
Other study ID # CLH005
Secondary ID
Status Withdrawn
Phase N/A
First received April 20, 2011
Last updated December 28, 2011
Start date June 2011
Est. completion date October 2014

Study information

Verified date December 2011
Source Oraya Therapeutics, Inc.
Contact n/a
Is FDA regulated No
Health authority Italy: Comitato Etico Fondazione Centro S. Raffaele del Monte TaborUK: Yorkshire and the Humber - Sheffield Research Ethics Committee
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date October 2014
Est. primary completion date October 2012
Accepts healthy volunteers No
Gender Both
Age group 50 Years and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Device:
IRay
low voltage external beam radiosurgery
IRay
low voltage external beam radiosurgery

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Oraya Therapeutics, Inc.

Countries where clinical trial is conducted

Italy,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Lucentis injections during first 52 weeks 52 weeks No
Secondary Change in mean VA 52 weeks No
Secondary Loss/gain of letters of BCVA week 52 No
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