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)

Age-related Macular Degeneration Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01339949
• Other study ID #: CLH005
• Status: Withdrawn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• Status: Withdrawn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

• Age-related Macular Degeneration
• AMD
• Choroidal Neovascularization
• Macular Degeneration
• Wet Age-related Macular Degeneration
• Wet AMD

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