Overview

This trial is active, not recruiting.

Conditions amd, wet amd, age-related macular degeneration, wet age-related macular degeneration, macular degeneration, eye diseases, retinal diseases
Treatment iray
Phase phase 2
Sponsor Oraya Therapeutics, Inc.
Start date November 2009
End date May 2012
Trial size 210 participants
Trial identifier NCT01016873, CLH002

Summary

The purpose of this study is to confirm the safety and establish the effectiveness of two doses from the IRay System for the treatment of wet AMD.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
16 Gy IRay + PRN Lucentis®
iray
Low voltage stereotactic radiotherapy system
(Sham Comparator)
Sham 16 Gy IRay + PRN Lucentis®
iray
Low voltage stereotactic radiotherapy system
(Experimental)
24 Gy IRay + PRN Lucentis®
iray
Low voltage stereotactic radiotherapy system
(Sham Comparator)
Sham 24 Gy IRay + PRN Lucentis®
iray
Low voltage stereotactic radiotherapy system

Primary Outcomes

Measure
Number of Lucentis® injections.
time frame: During the first 52 weeks.

Secondary Outcomes

Measure
Change in mean Visual Acuity (VA).
time frame: Weeks 12, 28, 52 and 104.
Loss of < 15 letters of Best Correct Visual Acuity (BCVA).
time frame: Weeks 12, 28 and 52.
Gain of ≥ 15 letters of BCVA.
time frame: Weeks 12, 28 and 52.
Gain of ≥ 0 letters of BCVA.
time frame: Weeks 12, 28 and 52.
Time from mandatory injection at Day 0 to the first PRN injection.
time frame: To Be Determined
Total number of Lucentis® injections during the first 12, 28, and 104 weeks.
time frame: Week 12, 28, and 104
Change in total lesion and CNV size.
time frame: Week 12, 28 and 52.

Eligibility Criteria

Male or female participants at least 50 years old.

Inclusion Criteria: - Patients must have neovascular AMD diagnosed within the previous 3 years, have received at least 3 injections with Lucentis® or Avastin® within the previous year and have the need for treatment with anti-VEGF therapy due to increased fluid or persistent cysts on OCT, or leakage on FA. - Patients 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 the lesion perimeter. - The distance from the center of the fovea to the nearest edge of the optic disc should be not less than 3 mm. - Patients must Patient 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. - Patient 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: - CNV due to causes other than AMD, including ocular histoplasmosis syndrome, angioid streaks, multifocal choroiditis, choroidal rupture, or pathologic myopia (spherical equivalent ≥ -8 diopters). - An axial length of ≤20 mm or ≥26 mm. - Previously diagnosed with Diabetes Mellitus and/or an HbA1c of >6.5%, and 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), ocular photodynamic therapy, radiation therapy to the head or neck in the study eye. - Previous posterior vitrectomy, or any surgery in the study eye within 6 months or YAG capsulotomy within 3 months prior to the screening visit.

Additional Information

Official title A Double-masked, Sham Controlled, Dose-ranging Study to Evaluate the Safety and Effectiveness of Low Voltage Stereotactic Radiosurgery in Patients With Choroidal Neovascularization (CNV) Secondary to Age-related Macular Degeneration (AMD)
Description The purpose of this study is to confirm the safety of low voltage external beam radiotherapy using the IRay System at two dose levels for the treatment of CNV secondary to neovascular AMD and to determine if the IRay System is effective in sparing the number of Lucentis injections during the first 12 months.
Trial information was received from ClinicalTrials.gov and was last updated in June 2012.
Information provided to ClinicalTrials.gov by Oraya Therapeutics, Inc..