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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01016873
Recruitment Status : Completed
First Posted : November 20, 2009
Results First Posted : December 5, 2014
Last Update Posted : December 5, 2014
Sponsor:
Information provided by (Responsible Party):
Oraya Therapeutics, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions AMD
Wet AMD
Age-Related Macular Degeneration
Wet Age-Related Macular Degeneration
Macular Degeneration
Eye Diseases
Retinal Diseases
Intervention Device: IRay
Enrollment 230
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 16 Gy IRay 24 Gy IRay Sham IRay
Hide Arm/Group Description

16 Gy IRay + PRN Lucentis®

IRay: Low voltage stereotactic radiotherapy system

24 Gy IRay + PRN Lucentis®

IRay: Low voltage stereotactic radiotherapy system

Sham 24 or 16 Gy IRay + PRN Lucentis®

IRay: Low voltage stereotactic radiotherapy system
Period Title: 12 Months
Started 75 75 80
Completed 74 72 79
Not Completed 1 3 1
Period Title: 24 Months
Started 74 72 79
Completed 69 68 73
Not Completed 5 4 6
Period Title: 36 Months
Started 69 68 73
Completed 58 64 67
Not Completed 11 4 6
Arm/Group Title 16 Gy IRay 24 Gy IRay Sham IRay Total
Hide Arm/Group Description

16 Gy IRay + PRN Lucentis®

IRay: Low voltage stereotactic radiotherapy system

24 Gy IRay + PRN Lucentis®

IRay: Low voltage stereotactic radiotherapy system

Sham 16 or 24 Gy IRay + PRN Lucentis®

IRay: Low voltage stereotactic radiotherapy system

 Total of all reporting groups
Overall Number of Baseline Participants 75 75 80 230
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Mean (Standard Deviation)
Unit of measure:  Years
Age Number Analyzed 75 participants 75 participants 80 participants 230 participants
73.35  (7.18) 73.77  (8.26) 73.45  (7.14) 73.52  (7.51)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 75 participants 75 participants 80 participants 230 participants
Female
43
  57.3%
48
  64.0%
49
  61.3%
140
  60.9%
Male
32
  42.7%
27
  36.0%
31
  38.8%
90
  39.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 75 participants 75 participants 80 participants 230 participants
Czech Republic 48 29 47 124
Austria 4 20 4 28
Germany 6 7 10 23
United Kingdom 14 18 17 49
Italy 3 1 2 6
1.Primary Outcome
Title Number of Lucentis® Injections Up To And Including Week 52
Hide Description [Not Specified]
Time Frame During the first 52 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 16 Gy IRay 24 Gy IRay Sham IRay
Hide Arm/Group Description:

16 Gy IRay + PRN Lucentis®

IRay: Low voltage stereotactic radiotherapy system

24 Gy IRay + PRN Lucentis®

IRay: Low voltage stereotactic radiotherapy system

Sham 16 or 24 Gy IRay + PRN Lucentis®

IRay: Low voltage stereotactic radiotherapy system
Overall Number of Participants Analyzed 75 75 80
Mean (Standard Deviation)
Unit of Measure: Injections
2.64  (2.46) 2.44  (2.41) 3.73  (2.58)
2.Secondary Outcome
Title Change in Mean Visual Acuity (VA)
Hide Description [Not Specified]
Time Frame Weeks 12, 28, 52 and 104.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 16 Gy IRay 24 Gy IRay Sham IRay
Hide Arm/Group Description:

16 Gy IRay + PRN Lucentis®

IRay: Low voltage stereotactic radiotherapy system

24 Gy IRay + PRN Lucentis®

IRay: Low voltage stereotactic radiotherapy system

Sham 16 or 24 Gy IRay + PRN Lucentis®

IRay: Low voltage stereotactic radiotherapy system
Overall Number of Participants Analyzed 75 75 80
Mean (Standard Deviation)
Unit of Measure: Letters
Visual Acuity (VA) - Baseline 57.91  (12.72) 58.75  (12.79) 59.29  (13.09)
Mean change in VA Week 12, n = 73, 71, 78 0.86  (5.68) 1.85  (9.73) 2.06  (6.79)
Mean change in VA Week 28, n = 73, 73, 77 -0.33  (8.25) 2.04  (8.58) 1.42  (7.91)
Mean change in VA Week 52, n = 74, 72, 79 -0.28  (8.77) 0.40  (10.33) -0.58  (10.56)
Mean change in VA Week 104, n = 68, 68, 73 -10.03  (16.45) -7.49  (16.49) -6.71  (17.08)
3.Secondary Outcome
Title Percentage (Pct.) of Patients (Pts.) Losing < 15 Letters of Best Correct Visual Acuity (BCVA) From Baseline (Base.)
Hide Description [Not Specified]
Time Frame Weeks 12, 28 and 52.
Hide Outcome Measure Data
Hide Analysis Population Description

Number of Participants Analyzed:

  • Week 12: n = 73, 71, 78
  • Week 28: n = 73, 73, 77
  • Week 52: n = 74, 72, 79
Arm/Group Title 16 Gy IRay 24 Gy IRay Sham IRay
Hide Arm/Group Description:

16 Gy IRay + PRN Lucentis®

IRay: Low voltage stereotactic radiotherapy system

24 Gy IRay + PRN Lucentis®

IRay: Low voltage stereotactic radiotherapy system

Sham 16 or 24 Gy IRay + PRN Lucentis®

IRay: Low voltage stereotactic radiotherapy system
Overall Number of Participants Analyzed 75 75 80
Measure Type: Number
Unit of Measure: Percentage of Patients
Pct. of Pts. Losing <15 Letters From Base. - W12 100 97 97
Pct. of Pts. Losing <15 Letters From Base. - W28 97 96 97
Pct. of Pts. Losing <15 Letters From Base. - W52 93 89 92
4.Secondary Outcome
Title Percentage (Pct.) of Patients (Pts.) Gaining ≥ 15 Letters of Best Correct Visual Acuity (BCVA) From Baseline (Base.)
Hide Description [Not Specified]
Time Frame Weeks 12, 28 and 52.
Hide Outcome Measure Data
Hide Analysis Population Description

Number of Participants Analyzed:

  • Week 12: n = 73, 71, 78
  • Week 28: n = 73, 73, 77
  • Week 52: n = 74, 72, 79
Arm/Group Title 16 Gy IRay 24 Gy IRay Sham IRay
Hide Arm/Group Description:

16 Gy IRay + PRN Lucentis®

IRay: Low voltage stereotactic radiotherapy system

24 Gy IRay + PRN Lucentis®

IRay: Low voltage stereotactic radiotherapy system

Sham 16 or 24 Gy IRay + PRN Lucentis®

IRay: Low voltage stereotactic radiotherapy system
Overall Number of Participants Analyzed 75 75 80
Measure Type: Number
Unit of Measure: Proportion of Patients
Pct. of Pts. Gaining >=15 Letters from Base. -W12 0 6 1
Pct. of Pts. Gaining >=15 Letters from Base. -W28 4 4 3
Pct. of Pts. Gaining >=15 Letters from Base. -W52 4 4 5
5.Secondary Outcome
Title Percentage (Pct.) of Patients (Pts.) Gaining ≥ 0 Letters of Best Correct Visual Acuity (BCVA) From Baseline (Base.)
Hide Description [Not Specified]
Time Frame Weeks 12, 28 and 52.
Hide Outcome Measure Data
Hide Analysis Population Description

Number of Participants Analyzed:

  • Week 12: n = 73, 71, 78
  • Week 28: n = 73, 73, 77
  • Week 52: n = 74, 72, 79
Arm/Group Title 16 Gy IRay 24 Gy IRay Sham IRay
Hide Arm/Group Description:

16 Gy IRay + PRN Lucentis®

IRay: Low voltage stereotactic radiotherapy system

24 Gy IRay + PRN Lucentis®

IRay: Low voltage stereotactic radiotherapy system

Sham 16 or 24 Gy IRay + PRN Lucentis®

IRay: Low voltage stereotactic radiotherapy system
Overall Number of Participants Analyzed 75 75 80
Measure Type: Number
Unit of Measure: Percentage of Patients
Pct. of Pts. Gaining >=0 Letters From Base. - W12 60 65 74
Pct. of Pts. Gaining >=0 Letters From Base. - W28 52 62 64
Pct. of Pts. Gaining >=0 Letters From Base. - W52 53 57 57
6.Secondary Outcome
Title Time From Mandatory Injection at Day 0 to the First PRN Injection.
Hide Description [Not Specified]
Time Frame 52 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 16 Gy IRay 24 Gy IRay Sham IRay
Hide Arm/Group Description:

16 Gy IRay + PRN Lucentis®

IRay: Low voltage stereotactic radiotherapy system

24 Gy IRay + PRN Lucentis®

IRay: Low voltage stereotactic radiotherapy system

Sham 16 or 24 Gy IRay + PRN Lucentis®

IRay: Low voltage stereotactic radiotherapy system
Overall Number of Participants Analyzed 75 75 80
Median (95% Confidence Interval)
Unit of Measure: Weeks
16.29
(12.14 to 20.29)
16.71
(12.57 to 26.29)
13.14
(12.14 to 16.14)
7.Secondary Outcome
Title Total Number (No.) of Lucentis® Injections (Inject.) During The First 12, 28, and 104 Weeks.
Hide Description [Not Specified]
Time Frame Week 12, 28, and 104
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 16 Gy IRay 24 Gy IRay Sham IRay
Hide Arm/Group Description:

16 Gy IRay + PRN Lucentis®

IRay: Low voltage stereotactic radiotherapy system

24 Gy IRay + PRN Lucentis®

IRay: Low voltage stereotactic radiotherapy system

Sham 16 or 24 Gy IRay + PRN Lucentis®

IRay: Low voltage stereotactic radiotherapy system
Overall Number of Participants Analyzed 75 75 80
Mean (Standard Deviation)
Unit of Measure: Number of Injections
Mean No. of Injections - Week 12, n = 75,75,80 0.57  (0.70) 0.56  (0.74) 0.73  (0.78)
No. of Injections - Week 28, n = 75,75,80 1.51  (1.35) 1.28  (1.37) 1.83  (1.41)
Mean No. of Injections - Week 104, n=75,75,80 4.48  (3.94) 5.37  (4.57) 6.61  (4.28)
8.Secondary Outcome
Title Mean Change in Choroidal Neovascularization (CNV) as % of Lesion on Fluorescein Angiography (FA) From Baseline to Week 52
Hide Description [Not Specified]
Time Frame Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 16 Gy IRay 24 Gy IRay Sham IRay
Hide Arm/Group Description:

16 Gy IRay + PRN Lucentis®

IRay: Low voltage stereotactic radiotherapy system

24 Gy IRay + PRN Lucentis®

IRay: Low voltage stereotactic radiotherapy system

Sham 16 or 24 Gy IRay + PRN Lucentis®

IRay: Low voltage stereotactic radiotherapy system
Overall Number of Participants Analyzed 29 28 44
Mean (Standard Deviation)
Unit of Measure: CNV as % of Lesion
-0.16  (0.33) -0.18  (0.33) -0.10  (0.26)
Time Frame Adverse event reporting from Baseline through week 104.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 16 Gy IRay 24 Gy IRay Sham IRay
Hide Arm/Group Description

16 Gy IRay + PRN Lucentis®

IRay: Low voltage stereotactic radiotherapy system

24 Gy IRay + PRN Lucentis®

IRay: Low voltage stereotactic radiotherapy system

Sham 16 or 24 Gy IRay + PRN Lucentis®

IRay: Low voltage stereotactic radiotherapy system
All-Cause Mortality
16 Gy IRay 24 Gy IRay Sham IRay
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Hide Serious Adverse Events
16 Gy IRay 24 Gy IRay Sham IRay
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   12/75 (16.00%)      8/75 (10.67%)      7/80 (8.75%)    
Blood and lymphatic system disorders       
Microcytic anaemia  1/75 (1.33%)  1 0/75 (0.00%)  0 0/80 (0.00%)  0
Eye disorders       
Choroidal neovascularisation  0/75 (0.00%)  0 0/75 (0.00%)  0 1/80 (1.25%)  1
Retinal Vein Occlusion  0/75 (0.00%)  0 0/75 (0.00%)  0 1/80 (1.25%)  1
Gastrointestinal disorders       
Gastrointestinal disorder  1/75 (1.33%)  1 0/75 (0.00%)  0 0/80 (0.00%)  0
Rectal Haemorrhage  1/75 (1.33%)  1 0/75 (0.00%)  0 0/80 (0.00%)  0
Intestinal obstruction  0/75 (0.00%)  0 0/75 (0.00%)  0 1/80 (1.25%)  1
General disorders       
Impaired healing  0/75 (0.00%)  0 0/75 (0.00%)  0 1/80 (1.25%)  1
Infections and infestations       
Pneumonia  1/75 (1.33%)  1 2/75 (2.67%)  2 1/80 (1.25%)  1
Injury, poisoning and procedural complications       
Femur fracture  1/75 (1.33%)  1 0/75 (0.00%)  0 0/80 (0.00%)  0
Hip fracture  0/75 (0.00%)  0 0/75 (0.00%)  0 1/80 (1.25%)  1
Post procedural complication  0/75 (0.00%)  0 0/75 (0.00%)  0 1/80 (1.25%)  1
Upper limb fracture  0/75 (0.00%)  0 0/75 (0.00%)  0 1/80 (1.25%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Colorectal cancer  0/75 (0.00%)  0 1/75 (1.33%)  1 1/80 (1.25%)  1
Nervous system disorders       
Convulsion  0/75 (0.00%)  0 0/75 (0.00%)  0 1/80 (1.25%)  1
Intracranial haematoma  0/75 (0.00%)  0 0/75 (0.00%)  0 1/80 (1.25%)  1
Sciatica  1/75 (1.33%)  1 0/75 (0.00%)  0 0/80 (0.00%)  0
Stroke  0/75 (0.00%)  0 1/75 (1.33%)  1 0/80 (0.00%)  0
Renal and urinary disorders       
Urinary bladder polyp  1/75 (1.33%)  1 0/75 (0.00%)  0 0/80 (0.00%)  0
Reproductive system and breast disorders       
Colpocele  1/75 (1.33%)  1 0/75 (0.00%)  0 0/80 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Pulmonary embolism  2/75 (2.67%)  2 0/75 (0.00%)  0 0/80 (0.00%)  0
Pulmonary hypertension  1/75 (1.33%)  1 0/75 (0.00%)  0 0/80 (0.00%)  0
Surgical and medical procedures       
Limb operation  0/75 (0.00%)  0 2/75 (2.67%)  2 0/80 (0.00%)  0
Cyst drainage  0/75 (0.00%)  0 1/75 (1.33%)  1 0/80 (0.00%)  0
Foot operation  0/75 (0.00%)  0 1/75 (1.33%)  1 0/80 (0.00%)  0
Vascular disorders       
Hypertension  1/75 (1.33%)  1 0/75 (0.00%)  0 0/80 (0.00%)  0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 4%
16 Gy IRay 24 Gy IRay Sham IRay
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   20/75 (26.67%)      23/75 (30.67%)      24/80 (30.00%)    
Eye disorders       
Worsening of macular degeneration  7/75 (9.33%)  7 6/75 (8.00%)  6 8/80 (10.00%)  8
Retinal haemorrhage  4/75 (5.33%)  4 2/75 (2.67%)  2 6/80 (7.50%)  6
Visual acuity reduced  5/75 (6.67%)  5 3/75 (4.00%)  3 4/80 (5.00%)  4
Blepharitis  2/75 (2.67%)  2 7/75 (9.33%)  7 2/80 (2.50%)  2
Infections and infestations       
Nasopharyngitis  2/75 (2.67%)  2 7/75 (9.33%)  7 4/80 (5.00%)  4
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Denis O'Shaugnessy, Ph.D.
Organization: Oraya Therapeutics Inc.
Phone: 917-417-3974
EMail: doshaughnessy@orayainc.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Oraya Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT01016873    
Other Study ID Numbers: CLH002
First Submitted: November 19, 2009
First Posted: November 20, 2009
Results First Submitted: November 13, 2014
Results First Posted: December 5, 2014
Last Update Posted: December 5, 2014