Phase 2
N=230
INTREPID - IRay Plus Anti-VEGF Treatment For Patients With Wet AMD
AMD · Wet AMD · Age-Related Macular Degeneration · Wet Age-Related Macular Degeneration · Macular Degeneration
Bottom Line
View on ClinicalTrials.gov: NCT01016873 ↗Enrolled (actual)
230
Serious AEs
11.7%
Results posted
Dec 2014
Primary outcome: Primary: Number of Lucentis® Injections Up To And Including Week 52 — 2.64; 2.44; 3.73 Injections
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- IRay (Device)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Oraya Therapeutics, Inc.
- Primary completion
- May 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Lucentis® Injections Up To And Including Week 52 |
2.64; 2.44; 3.73 | — |
| SECONDARY Change in Mean Visual Acuity (VA) |
57.91; 58.75; 59.29; 0.86; 1.85; 2.06 | — |
| SECONDARY Percentage (Pct.) of Patients (Pts.) Losing < 15 Letters of Best Correct Visual Acuity (BCVA) From Baseline (Base.) |
100; 97; 97; 97; 96; 97 | — |
| SECONDARY Percentage (Pct.) of Patients (Pts.) Gaining ≥ 15 Letters of Best Correct Visual Acuity (BCVA) From Baseline (Base.) |
0; 6; 1; 4; 4; 3 | — |
| SECONDARY Percentage (Pct.) of Patients (Pts.) Gaining ≥ 0 Letters of Best Correct Visual Acuity (BCVA) From Baseline (Base.) |
60; 65; 74; 52; 62; 64 | — |
| SECONDARY Time From Mandatory Injection at Day 0 to the First PRN Injection. |
16.29; 16.71; 13.14 | — |
| SECONDARY Total Number (No.) of Lucentis® Injections (Inject.) During The First 12, 28, and 104 Weeks. |
0.57; 0.56; 0.73; 1.51; 1.28; 1.83 | — |
| SECONDARY Mean Change in Choroidal Neovascularization (CNV) as % of Lesion on Fluorescein Angiography (FA) From Baseline to Week 52 |
-0.16; -0.18; -0.10 | — |
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 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.
Data sourced from ClinicalTrials.gov (NCT01016873). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.