INTREPID - IRay Plus Anti-VEGF Treatment For Patients With Wet AMD

Oraya Therapeutics

Status and phase: Completed; Phase 2

Conditions: Age-Related Macular Degeneration; Macular Degeneration; Wet Age-Related Macular Degeneration; Wet AMD; AMD; Eye Diseases; Retinal Diseases

Treatments: Device: IRay

Study type: Interventional

Funder types: Industry

Identifiers

NCT01016873

CLH002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 230 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

230 participants in 4 patient groups

16 Gy IRay

Experimental group

Description:

16 Gy IRay + PRN Lucentis®

Treatment:

Device: IRay

Sham 16 Gy IRay

Sham Comparator group

Description:

Sham 16 Gy IRay + PRN Lucentis®

Treatment:

Device: IRay

24 Gy IRay

Experimental group

Description:

24 Gy IRay + PRN Lucentis®

Treatment:

Device: IRay

Sham 24 Gy IRay

Sham Comparator group

Description:

Sham 24 Gy IRay + PRN Lucentis®

Treatment:

Device: IRay