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)

NCT01339949 | Withdrawn DMC

• 1 other identifier: CLH005
• Study Type: interventional
• Target: N/A
• Locations: 2 countries
• Sites: 3

Brief 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.

Conditions

Wet Age-related Macular Degeneration; Age-related Macular Degeneration; AMD; Wet AMD; Macular Degeneration

Keywords

AMD; wet AMD; Macular Degeneration; wet Age-related Macular Degeneration; Age-Related Macular Degeneration; IRay; radiation; Oraya; Oraya Therapeutics, Inc; Low-voltage stereotactic radiosurgery; radiosurgery; x-ray; Lucentis; external beam radiation

Outcome Measures

Primary Outcomes (1)

• Number of Lucentis injections during first 52 weeks

  52 weeks

Secondary Outcomes (2)

• Change in mean VA

  52 weeks

• Loss/gain of letters of BCVA

  week 52

Study Arms (2)

24 Gy radiation

EXPERIMENTAL

Device: IRay

Sham 24 Gy radiation

SHAM COMPARATOR

Device: IRay

Interventions

IRay DEVICE

low voltage external beam radiosurgery

24 Gy radiation

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Oraya Therapeutics, Inc.: lead

Study Sites (3)

Università Vita-Salute Istituto Scientifico San Raffaele

Milan, Italy

Location

King's College Hospital

London, United Kingdom

Location

Manchester Royal Eye Hospital

Manchester, United Kingdom

Location

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 20, 2011
• First Posted: April 21, 2011
• Study Start: June 1, 2011
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2014
• Last Updated: December 30, 2011

Record last verified: 2011-12

Locations

GB (2); IT (1)