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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 16 Gy IRay | Experimental | 16 Gy IRay + PRN Lucentis® |
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| Sham 16 Gy IRay | Sham Comparator | Sham 16 Gy IRay + PRN Lucentis® |
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| 24 Gy IRay | Experimental | 24 Gy IRay + PRN Lucentis® |
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| Sham 24 Gy IRay | Sham Comparator | Sham 24 Gy IRay + PRN Lucentis® |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IRay | Device | Low voltage stereotactic radiotherapy system |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Lucentis® Injections Up To And Including Week 52 | During the first 52 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Mean Visual Acuity (VA) | Weeks 12, 28, 52 and 104. | |
| Percentage (Pct.) of Patients (Pts.) Losing < 15 Letters of Best Correct Visual Acuity (BCVA) From Baseline (Base.) | Weeks 12, 28 and 52. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Denis O'Shaughnessy, Ph.D. | Oraya Therapeutics, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LKH Graz | Graz | A-8036 | Austria | |||
| Universitätsklinik Innsbruck |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32844399 | Derived | Evans JR, Igwe C, Jackson TL, Chong V. Radiotherapy for neovascular age-related macular degeneration. Cochrane Database Syst Rev. 2020 Aug 26;8(8):CD004004. doi: 10.1002/14651858.CD004004.pub4. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 16 Gy IRay | 16 Gy IRay + PRN Lucentis® IRay: Low voltage stereotactic radiotherapy system |
| FG001 | 24 Gy IRay | 24 Gy IRay + PRN Lucentis® IRay: Low voltage stereotactic radiotherapy system |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| 12 Months |
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| Percentage (Pct.) of Patients (Pts.) Gaining ≥ 15 Letters of Best Correct Visual Acuity (BCVA) From Baseline (Base.) | Weeks 12, 28 and 52. |
| Percentage (Pct.) of Patients (Pts.) Gaining ≥ 0 Letters of Best Correct Visual Acuity (BCVA) From Baseline (Base.) | Weeks 12, 28 and 52. |
| Time From Mandatory Injection at Day 0 to the First PRN Injection. | 52 Weeks |
| Total Number (No.) of Lucentis® Injections (Inject.) During The First 12, 28, and 104 Weeks. | Week 12, 28, and 104 |
| Mean Change in Choroidal Neovascularization (CNV) as % of Lesion on Fluorescein Angiography (FA) From Baseline to Week 52 | Week 52 |
| Innsbruck |
| A-6020 |
| Austria |
| Hanusch Krankenhaus Wien | Vienna | A-1140 | Austria |
| Ordination Prof. Michael Stur | Vienna | A-1180 | Austria |
| Fakultni Nemocnice Brno | Brno | 625 00 | Czechia |
| Fakultni nemocnice Hradec Kralove | Hradec Králové | 500 05 | Czechia |
| Fakultni Nemocnice Olomouc | Olomouc | 775 20 | Czechia |
| Faculty Hospital Kralovske Vinohrady | Prague | 100 34 | Czechia |
| General Faculty Hospital Prague | Prague | 128 08 | Czechia |
| Military Hospital Prague | Prague | 169 02 | Czechia |
| Kopfklinikum University Hospital Heidelberg | Heidelberg | Baden-Wurttemberg | 69120 | Germany |
| University Eye Hospital | Tübingen | Baden-Wurttemberg | 72076 | Germany |
| Klinik für Augenheilkunde | Neubrandenburg | Mecklenburg-Vorpommern | 17036 | Germany |
| Università Vita-Salute Istituto Scientifico San Raffaele | Milan | I-20132 | Italy |
| Royal Victoria Hospital | Belfast | BT12 6BA | United Kingdom |
| Bradford Royal Infirmary | Bradford | BDP 6RJ | United Kingdom |
| Torbay Hospital | Devon | TQ2 7AA | United Kingdom |
| King's College | London | SE5 9RS | United Kingdom |
| Manchester Royal Eye Hospital | Manchester | M13 9WL | United Kingdom |
| Southampton General Hospital | Southampton | SO16 6YD | United Kingdom |
| Royal Wolverhampton Hospital NHS Foundation Trust | Wolverhampton | WV3 9QR | United Kingdom |
| FG002 | Sham IRay | Sham 24 or 16 Gy IRay + PRN Lucentis® IRay: Low voltage stereotactic radiotherapy system |
| COMPLETED |
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| NOT COMPLETED |
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| 24 Months |
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| 36 Months |
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| ID | Title | Description |
|---|---|---|
| BG000 | 16 Gy IRay | 16 Gy IRay + PRN Lucentis® IRay: Low voltage stereotactic radiotherapy system |
| BG001 | 24 Gy IRay | 24 Gy IRay + PRN Lucentis® IRay: Low voltage stereotactic radiotherapy system |
| BG002 | Sham IRay | Sham 16 or 24 Gy IRay + PRN Lucentis® IRay: Low voltage stereotactic radiotherapy system |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Lucentis® Injections Up To And Including Week 52 | Posted | Mean | Standard Deviation | Injections | During the first 52 weeks. |
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| Secondary | Change in Mean Visual Acuity (VA) | Posted | Mean | Standard Deviation | Letters | Weeks 12, 28, 52 and 104. |
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| Secondary | Percentage (Pct.) of Patients (Pts.) Losing < 15 Letters of Best Correct Visual Acuity (BCVA) From Baseline (Base.) | Number of Participants Analyzed:
| Posted | Number | Percentage of Patients | Weeks 12, 28 and 52. |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Percentage (Pct.) of Patients (Pts.) Gaining ≥ 15 Letters of Best Correct Visual Acuity (BCVA) From Baseline (Base.) | Number of Participants Analyzed:
| Posted | Number | Proportion of Patients | Weeks 12, 28 and 52. |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Percentage (Pct.) of Patients (Pts.) Gaining ≥ 0 Letters of Best Correct Visual Acuity (BCVA) From Baseline (Base.) | Number of Participants Analyzed:
| Posted | Number | Percentage of Patients | Weeks 12, 28 and 52. |
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| ||||||||||||||||||||||||||||||||||
| Secondary | Time From Mandatory Injection at Day 0 to the First PRN Injection. | Posted | Median | 95% Confidence Interval | Weeks | 52 Weeks |
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| Secondary | Total Number (No.) of Lucentis® Injections (Inject.) During The First 12, 28, and 104 Weeks. | Posted | Mean | Standard Deviation | Number of Injections | Week 12, 28, and 104 |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Mean Change in Choroidal Neovascularization (CNV) as % of Lesion on Fluorescein Angiography (FA) From Baseline to Week 52 | Posted | Mean | Standard Deviation | CNV as % of Lesion | Week 52 |
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Adverse event reporting from Baseline through week 104.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 16 Gy IRay | 16 Gy IRay + PRN Lucentis® IRay: Low voltage stereotactic radiotherapy system | 12 | 75 | 20 | 75 | ||
| EG001 | 24 Gy IRay | 24 Gy IRay + PRN Lucentis® IRay: Low voltage stereotactic radiotherapy system | 8 | 75 | 23 | 75 | ||
| EG002 | Sham IRay | Sham 16 or 24 Gy IRay + PRN Lucentis® IRay: Low voltage stereotactic radiotherapy system | 7 | 80 | 24 | 80 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Microcytic anaemia | Blood and lymphatic system disorders |
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| Choroidal neovascularisation | Eye disorders |
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| Retinal Vein Occlusion | Eye disorders |
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| Gastrointestinal disorder | Gastrointestinal disorders |
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| Rectal Haemorrhage | Gastrointestinal disorders |
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| Intestinal obstruction | Gastrointestinal disorders |
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| Impaired healing | General disorders |
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| Pneumonia | Infections and infestations |
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| Femur fracture | Injury, poisoning and procedural complications |
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| Hip fracture | Injury, poisoning and procedural complications |
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| Post procedural complication | Injury, poisoning and procedural complications |
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| Upper limb fracture | Injury, poisoning and procedural complications |
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| Colorectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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| Convulsion | Nervous system disorders |
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| Intracranial haematoma | Nervous system disorders |
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| Sciatica | Nervous system disorders |
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| Stroke | Nervous system disorders |
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| Urinary bladder polyp | Renal and urinary disorders |
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| Colpocele | Reproductive system and breast disorders |
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| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders |
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| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders |
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| Limb operation | Surgical and medical procedures |
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| Cyst drainage | Surgical and medical procedures |
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| Foot operation | Surgical and medical procedures |
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| Hypertension | Vascular disorders |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Worsening of macular degeneration | Eye disorders |
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| Retinal haemorrhage | Eye disorders |
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| Visual acuity reduced | Eye disorders |
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| Blepharitis | Eye disorders |
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| Nasopharyngitis | Infections and infestations |
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Institution and the Principal Investigator agree not to publish or issue a press release or authorize the publication or presentation of any Study Results without obtaining Oraya's prior written approval.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Denis O'Shaugnessy, Ph.D. | Oraya Therapeutics Inc. | 917-417-3974 | doshaughnessy@orayainc.com |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D005128 | Eye Diseases |
| D012164 | Retinal Diseases |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
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| Austria |
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| Germany |
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| United Kingdom |
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| Italy |
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