INTREPID - IRay Plus Anti-VEGF Treatment For Patients With Wet AMD
Condition: AMD; Wet AMD; Age-Related Macular Degeneration; Wet Age-Related Macular Degeneration; Macular Degeneration; Eye Diseases; Retinal Diseases
MeSH terms: Macular Degeneration; Eye Diseases; Retinal Diseases
Intervention: IRay
Intervention description: Low voltage stereotactic radiotherapy system
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 230.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: Oraya; Oraya Therapeutics, Inc.; low voltage stereotactic radiotherapy; radiotherapy; IRay; Ranibizumab; Lucentis; AMD; Macular Degeneration; xray; radiation; x ray; external beam radiation; radiosurgery

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.
    

Eligibility criteria:

        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.