Trial Outcomes & Findings for INTREPID - IRay Plus Anti-VEGF Treatment For Patients With Wet AMD (NCT NCT01016873)

NCT ID: NCT01016873

Last Updated: 2014-12-05

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 230 participants
• Primary outcome timeframe: During the first 52 weeks.
• Results posted on: 2014-12-05

Participant Flow

Participant milestones

Measure	16 Gy IRay 16 Gy IRay + PRN Lucentis® IRay: Low voltage stereotactic radiotherapy system	24 Gy IRay 24 Gy IRay + PRN Lucentis® IRay: Low voltage stereotactic radiotherapy system	Sham IRay Sham 24 or 16 Gy IRay + PRN Lucentis® IRay: Low voltage stereotactic radiotherapy system
12 Months STARTED	75	75	80
12 Months COMPLETED	74	72	79
12 Months NOT COMPLETED	1	3	1
24 Months STARTED	74	72	79
24 Months COMPLETED	69	68	73
24 Months NOT COMPLETED	5	4	6
36 Months STARTED	69	68	73
36 Months COMPLETED	58	64	67
36 Months NOT COMPLETED	11	4	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	16 Gy IRay n=75 Participants 16 Gy IRay + PRN Lucentis® IRay: Low voltage stereotactic radiotherapy system	24 Gy IRay n=75 Participants 24 Gy IRay + PRN Lucentis® IRay: Low voltage stereotactic radiotherapy system	Sham IRay n=80 Participants Sham 16 or 24 Gy IRay + PRN Lucentis® IRay: Low voltage stereotactic radiotherapy system	Total n=230 Participants Total of all reporting groups
Age, Customized Age	73.35 years STANDARD_DEVIATION 7.18 • n=93 Participants	73.77 years STANDARD_DEVIATION 8.26 • n=4 Participants	73.45 years STANDARD_DEVIATION 7.14 • n=27 Participants	73.52 years STANDARD_DEVIATION 7.51 • n=483 Participants
Sex: Female, Male Female	43 Participants n=93 Participants	48 Participants n=4 Participants	49 Participants n=27 Participants	140 Participants n=483 Participants
Sex: Female, Male Male	32 Participants n=93 Participants	27 Participants n=4 Participants	31 Participants n=27 Participants	90 Participants n=483 Participants
Region of Enrollment Czech Republic	48 participants n=93 Participants	29 participants n=4 Participants	47 participants n=27 Participants	124 participants n=483 Participants
Region of Enrollment Austria	4 participants n=93 Participants	20 participants n=4 Participants	4 participants n=27 Participants	28 participants n=483 Participants
Region of Enrollment Germany	6 participants n=93 Participants	7 participants n=4 Participants	10 participants n=27 Participants	23 participants n=483 Participants
Region of Enrollment United Kingdom	14 participants n=93 Participants	18 participants n=4 Participants	17 participants n=27 Participants	49 participants n=483 Participants
Region of Enrollment Italy	3 participants n=93 Participants	1 participants n=4 Participants	2 participants n=27 Participants	6 participants n=483 Participants

PRIMARY outcome

Timeframe: During the first 52 weeks.

Outcome measures

Measure	16 Gy IRay n=75 Participants 16 Gy IRay + PRN Lucentis® IRay: Low voltage stereotactic radiotherapy system	24 Gy IRay n=75 Participants 24 Gy IRay + PRN Lucentis® IRay: Low voltage stereotactic radiotherapy system	Sham IRay n=80 Participants Sham 16 or 24 Gy IRay + PRN Lucentis® IRay: Low voltage stereotactic radiotherapy system
Number of Lucentis® Injections Up To And Including Week 52	2.64 Injections Standard Deviation 2.46	2.44 Injections Standard Deviation 2.41	3.73 Injections Standard Deviation 2.58

SECONDARY outcome

Timeframe: Weeks 12, 28, 52 and 104.

Outcome measures

Measure	16 Gy IRay n=75 Participants 16 Gy IRay + PRN Lucentis® IRay: Low voltage stereotactic radiotherapy system	24 Gy IRay n=75 Participants 24 Gy IRay + PRN Lucentis® IRay: Low voltage stereotactic radiotherapy system	Sham IRay n=80 Participants Sham 16 or 24 Gy IRay + PRN Lucentis® IRay: Low voltage stereotactic radiotherapy system
Change in Mean Visual Acuity (VA) Visual Acuity (VA) - Baseline	57.91 Letters Standard Deviation 12.72	58.75 Letters Standard Deviation 12.79	59.29 Letters Standard Deviation 13.09
Change in Mean Visual Acuity (VA) Mean change in VA Week 12, n = 73, 71, 78	0.86 Letters Standard Deviation 5.68	1.85 Letters Standard Deviation 9.73	2.06 Letters Standard Deviation 6.79
Change in Mean Visual Acuity (VA) Mean change in VA Week 28, n = 73, 73, 77	-0.33 Letters Standard Deviation 8.25	2.04 Letters Standard Deviation 8.58	1.42 Letters Standard Deviation 7.91
Change in Mean Visual Acuity (VA) Mean change in VA Week 52, n = 74, 72, 79	-0.28 Letters Standard Deviation 8.77	0.40 Letters Standard Deviation 10.33	-0.58 Letters Standard Deviation 10.56
Change in Mean Visual Acuity (VA) Mean change in VA Week 104, n = 68, 68, 73	-10.03 Letters Standard Deviation 16.45	-7.49 Letters Standard Deviation 16.49	-6.71 Letters Standard Deviation 17.08

SECONDARY outcome

Timeframe: Weeks 12, 28 and 52.

Population: Number of Participants Analyzed: * Week 12: n = 73, 71, 78 * Week 28: n = 73, 73, 77 * Week 52: n = 74, 72, 79

Outcome measures

Measure	16 Gy IRay n=75 Participants 16 Gy IRay + PRN Lucentis® IRay: Low voltage stereotactic radiotherapy system	24 Gy IRay n=75 Participants 24 Gy IRay + PRN Lucentis® IRay: Low voltage stereotactic radiotherapy system	Sham IRay n=80 Participants Sham 16 or 24 Gy IRay + PRN Lucentis® IRay: Low voltage stereotactic radiotherapy system
Percentage (Pct.) of Patients (Pts.) Losing < 15 Letters of Best Correct Visual Acuity (BCVA) From Baseline (Base.) Pct. of Pts. Losing <15 Letters From Base. - W12	100 Percentage of Patients	97 Percentage of Patients	97 Percentage of Patients
Percentage (Pct.) of Patients (Pts.) Losing < 15 Letters of Best Correct Visual Acuity (BCVA) From Baseline (Base.) Pct. of Pts. Losing <15 Letters From Base. - W28	97 Percentage of Patients	96 Percentage of Patients	97 Percentage of Patients
Percentage (Pct.) of Patients (Pts.) Losing < 15 Letters of Best Correct Visual Acuity (BCVA) From Baseline (Base.) Pct. of Pts. Losing <15 Letters From Base. - W52	93 Percentage of Patients	89 Percentage of Patients	92 Percentage of Patients

SECONDARY outcome

Timeframe: Weeks 12, 28 and 52.

Population: Number of Participants Analyzed: * Week 12: n = 73, 71, 78 * Week 28: n = 73, 73, 77 * Week 52: n = 74, 72, 79

Outcome measures

Measure	16 Gy IRay n=75 Participants 16 Gy IRay + PRN Lucentis® IRay: Low voltage stereotactic radiotherapy system	24 Gy IRay n=75 Participants 24 Gy IRay + PRN Lucentis® IRay: Low voltage stereotactic radiotherapy system	Sham IRay n=80 Participants Sham 16 or 24 Gy IRay + PRN Lucentis® IRay: Low voltage stereotactic radiotherapy system
Percentage (Pct.) of Patients (Pts.) Gaining ≥ 15 Letters of Best Correct Visual Acuity (BCVA) From Baseline (Base.) Pct. of Pts. Gaining >=15 Letters from Base. -W12	0 Proportion of Patients	6 Proportion of Patients	1 Proportion of Patients
Percentage (Pct.) of Patients (Pts.) Gaining ≥ 15 Letters of Best Correct Visual Acuity (BCVA) From Baseline (Base.) Pct. of Pts. Gaining >=15 Letters from Base. -W28	4 Proportion of Patients	4 Proportion of Patients	3 Proportion of Patients
Percentage (Pct.) of Patients (Pts.) Gaining ≥ 15 Letters of Best Correct Visual Acuity (BCVA) From Baseline (Base.) Pct. of Pts. Gaining >=15 Letters from Base. -W52	4 Proportion of Patients	4 Proportion of Patients	5 Proportion of Patients

SECONDARY outcome

Timeframe: Weeks 12, 28 and 52.

Population: Number of Participants Analyzed: * Week 12: n = 73, 71, 78 * Week 28: n = 73, 73, 77 * Week 52: n = 74, 72, 79

Outcome measures

Measure	16 Gy IRay n=75 Participants 16 Gy IRay + PRN Lucentis® IRay: Low voltage stereotactic radiotherapy system	24 Gy IRay n=75 Participants 24 Gy IRay + PRN Lucentis® IRay: Low voltage stereotactic radiotherapy system	Sham IRay n=80 Participants Sham 16 or 24 Gy IRay + PRN Lucentis® IRay: Low voltage stereotactic radiotherapy system
Percentage (Pct.) of Patients (Pts.) Gaining ≥ 0 Letters of Best Correct Visual Acuity (BCVA) From Baseline (Base.) Pct. of Pts. Gaining >=0 Letters From Base. - W12	60 Percentage of Patients	65 Percentage of Patients	74 Percentage of Patients
Percentage (Pct.) of Patients (Pts.) Gaining ≥ 0 Letters of Best Correct Visual Acuity (BCVA) From Baseline (Base.) Pct. of Pts. Gaining >=0 Letters From Base. - W28	52 Percentage of Patients	62 Percentage of Patients	64 Percentage of Patients
Percentage (Pct.) of Patients (Pts.) Gaining ≥ 0 Letters of Best Correct Visual Acuity (BCVA) From Baseline (Base.) Pct. of Pts. Gaining >=0 Letters From Base. - W52	53 Percentage of Patients	57 Percentage of Patients	57 Percentage of Patients

SECONDARY outcome

Timeframe: 52 Weeks

Outcome measures

Measure	16 Gy IRay n=75 Participants 16 Gy IRay + PRN Lucentis® IRay: Low voltage stereotactic radiotherapy system	24 Gy IRay n=75 Participants 24 Gy IRay + PRN Lucentis® IRay: Low voltage stereotactic radiotherapy system	Sham IRay n=80 Participants Sham 16 or 24 Gy IRay + PRN Lucentis® IRay: Low voltage stereotactic radiotherapy system
Time From Mandatory Injection at Day 0 to the First PRN Injection.	16.29 Weeks Interval 12.14 to 20.29	16.71 Weeks Interval 12.57 to 26.29	13.14 Weeks Interval 12.14 to 16.14

SECONDARY outcome

Timeframe: Week 12, 28, and 104

Outcome measures

Measure	16 Gy IRay n=75 Participants 16 Gy IRay + PRN Lucentis® IRay: Low voltage stereotactic radiotherapy system	24 Gy IRay n=75 Participants 24 Gy IRay + PRN Lucentis® IRay: Low voltage stereotactic radiotherapy system	Sham IRay n=80 Participants Sham 16 or 24 Gy IRay + PRN Lucentis® IRay: Low voltage stereotactic radiotherapy system
Total Number (No.) of Lucentis® Injections (Inject.) During The First 12, 28, and 104 Weeks. Mean No. of Injections - Week 12, n = 75,75,80	0.57 Number of Injections Standard Deviation 0.70	0.56 Number of Injections Standard Deviation 0.74	0.73 Number of Injections Standard Deviation 0.78
Total Number (No.) of Lucentis® Injections (Inject.) During The First 12, 28, and 104 Weeks. No. of Injections - Week 28, n = 75,75,80	1.51 Number of Injections Standard Deviation 1.35	1.28 Number of Injections Standard Deviation 1.37	1.83 Number of Injections Standard Deviation 1.41
Total Number (No.) of Lucentis® Injections (Inject.) During The First 12, 28, and 104 Weeks. Mean No. of Injections - Week 104, n=75,75,80	4.48 Number of Injections Standard Deviation 3.94	5.37 Number of Injections Standard Deviation 4.57	6.61 Number of Injections Standard Deviation 4.28

SECONDARY outcome

Timeframe: Week 52

Outcome measures

Measure	16 Gy IRay n=29 Participants 16 Gy IRay + PRN Lucentis® IRay: Low voltage stereotactic radiotherapy system	24 Gy IRay n=28 Participants 24 Gy IRay + PRN Lucentis® IRay: Low voltage stereotactic radiotherapy system	Sham IRay n=44 Participants Sham 16 or 24 Gy IRay + PRN Lucentis® IRay: Low voltage stereotactic radiotherapy system
Mean Change in Choroidal Neovascularization (CNV) as % of Lesion on Fluorescein Angiography (FA) From Baseline to Week 52	-0.16 CNV as % of Lesion Standard Deviation 0.33	-0.18 CNV as % of Lesion Standard Deviation 0.33	-0.10 CNV as % of Lesion Standard Deviation 0.26

Adverse Events

16 Gy IRay

Serious events: 12 serious events

Other events: 20 other events

Deaths: 0 deaths

24 Gy IRay

Serious events: 8 serious events

Other events: 23 other events

Deaths: 0 deaths

Sham IRay

Serious events: 7 serious events

Other events: 24 other events

Deaths: 0 deaths

Serious adverse events

Measure	16 Gy IRay n=75 participants at risk 16 Gy IRay + PRN Lucentis® IRay: Low voltage stereotactic radiotherapy system	24 Gy IRay n=75 participants at risk 24 Gy IRay + PRN Lucentis® IRay: Low voltage stereotactic radiotherapy system	Sham IRay n=80 participants at risk Sham 16 or 24 Gy IRay + PRN Lucentis® IRay: Low voltage stereotactic radiotherapy system
Blood and lymphatic system disorders Microcytic anaemia	1.3% 1/75 • Number of events 1 • Adverse event reporting from Baseline through week 104.	0.00% 0/75 • Adverse event reporting from Baseline through week 104.	0.00% 0/80 • Adverse event reporting from Baseline through week 104.
Eye disorders Choroidal neovascularisation	0.00% 0/75 • Adverse event reporting from Baseline through week 104.	0.00% 0/75 • Adverse event reporting from Baseline through week 104.	1.2% 1/80 • Number of events 1 • Adverse event reporting from Baseline through week 104.
Eye disorders Retinal Vein Occlusion	0.00% 0/75 • Adverse event reporting from Baseline through week 104.	0.00% 0/75 • Adverse event reporting from Baseline through week 104.	1.2% 1/80 • Number of events 1 • Adverse event reporting from Baseline through week 104.
Gastrointestinal disorders Gastrointestinal disorder	1.3% 1/75 • Number of events 1 • Adverse event reporting from Baseline through week 104.	0.00% 0/75 • Adverse event reporting from Baseline through week 104.	0.00% 0/80 • Adverse event reporting from Baseline through week 104.
Gastrointestinal disorders Rectal Haemorrhage	1.3% 1/75 • Number of events 1 • Adverse event reporting from Baseline through week 104.	0.00% 0/75 • Adverse event reporting from Baseline through week 104.	0.00% 0/80 • Adverse event reporting from Baseline through week 104.
Gastrointestinal disorders Intestinal obstruction	0.00% 0/75 • Adverse event reporting from Baseline through week 104.	0.00% 0/75 • Adverse event reporting from Baseline through week 104.	1.2% 1/80 • Number of events 1 • Adverse event reporting from Baseline through week 104.
General disorders Impaired healing	0.00% 0/75 • Adverse event reporting from Baseline through week 104.	0.00% 0/75 • Adverse event reporting from Baseline through week 104.	1.2% 1/80 • Number of events 1 • Adverse event reporting from Baseline through week 104.
Infections and infestations Pneumonia	1.3% 1/75 • Number of events 1 • Adverse event reporting from Baseline through week 104.	2.7% 2/75 • Number of events 2 • Adverse event reporting from Baseline through week 104.	1.2% 1/80 • Number of events 1 • Adverse event reporting from Baseline through week 104.
Injury, poisoning and procedural complications Femur fracture	1.3% 1/75 • Number of events 1 • Adverse event reporting from Baseline through week 104.	0.00% 0/75 • Adverse event reporting from Baseline through week 104.	0.00% 0/80 • Adverse event reporting from Baseline through week 104.
Injury, poisoning and procedural complications Hip fracture	0.00% 0/75 • Adverse event reporting from Baseline through week 104.	0.00% 0/75 • Adverse event reporting from Baseline through week 104.	1.2% 1/80 • Number of events 1 • Adverse event reporting from Baseline through week 104.
Injury, poisoning and procedural complications Post procedural complication	0.00% 0/75 • Adverse event reporting from Baseline through week 104.	0.00% 0/75 • Adverse event reporting from Baseline through week 104.	1.2% 1/80 • Number of events 1 • Adverse event reporting from Baseline through week 104.
Injury, poisoning and procedural complications Upper limb fracture	0.00% 0/75 • Adverse event reporting from Baseline through week 104.	0.00% 0/75 • Adverse event reporting from Baseline through week 104.	1.2% 1/80 • Number of events 1 • Adverse event reporting from Baseline through week 104.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colorectal cancer	0.00% 0/75 • Adverse event reporting from Baseline through week 104.	1.3% 1/75 • Number of events 1 • Adverse event reporting from Baseline through week 104.	1.2% 1/80 • Number of events 1 • Adverse event reporting from Baseline through week 104.
Nervous system disorders Convulsion	0.00% 0/75 • Adverse event reporting from Baseline through week 104.	0.00% 0/75 • Adverse event reporting from Baseline through week 104.	1.2% 1/80 • Number of events 1 • Adverse event reporting from Baseline through week 104.
Nervous system disorders Intracranial haematoma	0.00% 0/75 • Adverse event reporting from Baseline through week 104.	0.00% 0/75 • Adverse event reporting from Baseline through week 104.	1.2% 1/80 • Number of events 1 • Adverse event reporting from Baseline through week 104.
Nervous system disorders Sciatica	1.3% 1/75 • Number of events 1 • Adverse event reporting from Baseline through week 104.	0.00% 0/75 • Adverse event reporting from Baseline through week 104.	0.00% 0/80 • Adverse event reporting from Baseline through week 104.
Nervous system disorders Stroke	0.00% 0/75 • Adverse event reporting from Baseline through week 104.	1.3% 1/75 • Number of events 1 • Adverse event reporting from Baseline through week 104.	0.00% 0/80 • Adverse event reporting from Baseline through week 104.
Renal and urinary disorders Urinary bladder polyp	1.3% 1/75 • Number of events 1 • Adverse event reporting from Baseline through week 104.	0.00% 0/75 • Adverse event reporting from Baseline through week 104.	0.00% 0/80 • Adverse event reporting from Baseline through week 104.
Reproductive system and breast disorders Colpocele	1.3% 1/75 • Number of events 1 • Adverse event reporting from Baseline through week 104.	0.00% 0/75 • Adverse event reporting from Baseline through week 104.	0.00% 0/80 • Adverse event reporting from Baseline through week 104.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	2.7% 2/75 • Number of events 2 • Adverse event reporting from Baseline through week 104.	0.00% 0/75 • Adverse event reporting from Baseline through week 104.	0.00% 0/80 • Adverse event reporting from Baseline through week 104.
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	1.3% 1/75 • Number of events 1 • Adverse event reporting from Baseline through week 104.	0.00% 0/75 • Adverse event reporting from Baseline through week 104.	0.00% 0/80 • Adverse event reporting from Baseline through week 104.
Surgical and medical procedures Limb operation	0.00% 0/75 • Adverse event reporting from Baseline through week 104.	2.7% 2/75 • Number of events 2 • Adverse event reporting from Baseline through week 104.	0.00% 0/80 • Adverse event reporting from Baseline through week 104.
Surgical and medical procedures Cyst drainage	0.00% 0/75 • Adverse event reporting from Baseline through week 104.	1.3% 1/75 • Number of events 1 • Adverse event reporting from Baseline through week 104.	0.00% 0/80 • Adverse event reporting from Baseline through week 104.
Surgical and medical procedures Foot operation	0.00% 0/75 • Adverse event reporting from Baseline through week 104.	1.3% 1/75 • Number of events 1 • Adverse event reporting from Baseline through week 104.	0.00% 0/80 • Adverse event reporting from Baseline through week 104.
Vascular disorders Hypertension	1.3% 1/75 • Number of events 1 • Adverse event reporting from Baseline through week 104.	0.00% 0/75 • Adverse event reporting from Baseline through week 104.	0.00% 0/80 • Adverse event reporting from Baseline through week 104.

Other adverse events

Measure	16 Gy IRay n=75 participants at risk 16 Gy IRay + PRN Lucentis® IRay: Low voltage stereotactic radiotherapy system	24 Gy IRay n=75 participants at risk 24 Gy IRay + PRN Lucentis® IRay: Low voltage stereotactic radiotherapy system	Sham IRay n=80 participants at risk Sham 16 or 24 Gy IRay + PRN Lucentis® IRay: Low voltage stereotactic radiotherapy system
Eye disorders Worsening of macular degeneration	9.3% 7/75 • Number of events 7 • Adverse event reporting from Baseline through week 104.	8.0% 6/75 • Number of events 6 • Adverse event reporting from Baseline through week 104.	10.0% 8/80 • Number of events 8 • Adverse event reporting from Baseline through week 104.
Eye disorders Retinal haemorrhage	5.3% 4/75 • Number of events 4 • Adverse event reporting from Baseline through week 104.	2.7% 2/75 • Number of events 2 • Adverse event reporting from Baseline through week 104.	7.5% 6/80 • Number of events 6 • Adverse event reporting from Baseline through week 104.
Eye disorders Visual acuity reduced	6.7% 5/75 • Number of events 5 • Adverse event reporting from Baseline through week 104.	4.0% 3/75 • Number of events 3 • Adverse event reporting from Baseline through week 104.	5.0% 4/80 • Number of events 4 • Adverse event reporting from Baseline through week 104.
Eye disorders Blepharitis	2.7% 2/75 • Number of events 2 • Adverse event reporting from Baseline through week 104.	9.3% 7/75 • Number of events 7 • Adverse event reporting from Baseline through week 104.	2.5% 2/80 • Number of events 2 • Adverse event reporting from Baseline through week 104.
Infections and infestations Nasopharyngitis	2.7% 2/75 • Number of events 2 • Adverse event reporting from Baseline through week 104.	9.3% 7/75 • Number of events 7 • Adverse event reporting from Baseline through week 104.	5.0% 4/80 • Number of events 4 • Adverse event reporting from Baseline through week 104.

Additional Information

Denis O'Shaugnessy, Ph.D.

Oraya Therapeutics Inc.

Phone: 917-417-3974

Email: doshaughnessy@orayainc.com

Results disclosure agreements

• Principal investigator is a sponsor employee 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.
• Publication restrictions are in place

Restriction type: OTHER