AMDPhase 2INTREPIDNCT01016873
INTREPID - IRay Plus Anti-VEGF Treatment For Patients With Wet AMD
A Phase 2 study testing IRay in people with AMD and Wet AMD, run by Oraya Therapeutics, Inc. at 21 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- AMD, Wet AMD, Age-Related Macular Degeneration
- What is being tested?
- IRay
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 230 participants
- Where
- 21 sitesin 5 countries
- Study dates
- Nov 2009to Apr 2014
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
21 sites in 5 countries.
21 sites in 5 countries
United Kingdom7 sites
Royal Victoria Hospital
Belfast, BT12 6BA
Bradford Royal Infirmary
Bradford, BDP 6RJ
Torbay Hospital
Devon, TQ2 7AA
King's College
London, SE5 9RS
Manchester Royal Eye Hospital
Manchester, M13 9WL
Southampton General Hospital
Southampton, SO16 6YD
Royal Wolverhampton Hospital NHS Foundation Trust
Wolverhampton, WV3 9QR
Czechia6 sites
Fakultni Nemocnice Brno
Brno, 625 00
Fakultni nemocnice Hradec Kralove
Hradec Králové, 500 05
Fakultni Nemocnice Olomouc
Olomouc, 775 20
Faculty Hospital Kralovske Vinohrady
Prague, 100 34
General Faculty Hospital Prague
Prague, 128 08
Military Hospital Prague
Prague, 169 02
Austria4 sites
LKH Graz
Graz, A-8036
Universitätsklinik Innsbruck
Innsbruck, A-6020
Hanusch Krankenhaus Wien
Vienna, A-1140
Ordination Prof. Michael Stur
Vienna, A-1180
Germany3 sites
Kopfklinikum University Hospital Heidelberg
Heidelberg, Baden-Wurttemberg, 69120
Klinik für Augenheilkunde
Neubrandenburg, Mecklenburg-Vorpommern, 17036
University Eye Hospital
Tübingen, Baden-Wurttemberg, 72076
Italy1 site
Università Vita-Salute Istituto Scientifico San Raffaele
Milan, I-20132
About this study
Official title: A Double-masked, Sham Controlled, Dose-ranging Study to Evaluate the Safety and Effectiveness of Low Voltage Stereotactic Radiosurgery in Patients With Choroidal Neovascularization (CNV) Secondary to Age-related Macular Degeneration (AMD)
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.
Read the detailed description
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.
- Conditions
- AMD, Wet AMD, Age-Related Macular Degeneration, Wet Age-Related Macular Degeneration, Macular Degeneration, Eye Diseases
- Being tested
- IRay
- Keywords
- Oraya, Oraya Therapeutics, Inc., low voltage stereotactic radiotherapy, radiotherapy, IRay, Ranibizumab, Lucentis, AMD, Macular Degeneration, xray, radiation, x ray, external beam radiation, radiosurgery
- Medical subject headings
- Macular Degeneration, Eye Diseases, Retinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IRayDevice
Low voltage stereotactic radiotherapy system
| Study group | Role | What they receive |
|---|---|---|
| 16 Gy IRay | Experimental | 16 Gy IRay + PRN Lucentis® Receives: Device: IRay |
| Sham 16 Gy IRay | Sham comparator | Sham 16 Gy IRay + PRN Lucentis® Receives: Device: IRay |
| 24 Gy IRay | Experimental | 24 Gy IRay + PRN Lucentis® Receives: Device: IRay |
| Sham 24 Gy IRay | Sham comparator | Sham 24 Gy IRay + PRN Lucentis® Receives: Device: IRay |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Lucentis® Injections Up To And Including Week 52
Measured: During the first 52 weeks.
Secondary outcomes (7)
Change in Mean Visual Acuity (VA)
Measured: Weeks 12, 28, 52 and 104.
Percentage (Pct.) of Patients (Pts.) Losing < 15 Letters of Best Correct Visual Acuity (BCVA) From Baseline (Base.)
Measured: Weeks 12, 28 and 52.
Percentage (Pct.) of Patients (Pts.) Gaining ≥ 15 Letters of Best Correct Visual Acuity (BCVA) From Baseline (Base.)
Measured: Weeks 12, 28 and 52.
Percentage (Pct.) of Patients (Pts.) Gaining ≥ 0 Letters of Best Correct Visual Acuity (BCVA) From Baseline (Base.)
Measured: Weeks 12, 28 and 52.
Time From Mandatory Injection at Day 0 to the First PRN Injection.
Measured: 52 Weeks
Total Number (No.) of Lucentis® Injections (Inject.) During The First 12, 28, and 104 Weeks.
Measured: Week 12, 28, and 104
Mean Change in Choroidal Neovascularization (CNV) as % of Lesion on Fluorescein Angiography (FA) From Baseline to Week 52
Measured: Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2009 (estimated)
- Study startNov 2009
- Primary completionMay 2012
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AMDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oraya Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Denis O'Shaughnessy, Ph.D., Study director, Oraya Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01016873
- Sponsor's protocol ID
- CLH002
- Acronym
- INTREPID
- Status last verified
- Dec 2014
- First submitted
- 19 Nov 2009
- Last updated
- 5 Dec 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 32844399
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-masked, Sham Controlled, Dose-ranging Study to Evaluate the Safety and Effectiveness of Low Voltage Stereotactic Radiosurgery in Patients With Choroidal Neovascularization (CNV) Secondary to Age-related Macular Degeneration (AMD)
- ClinicalTrials.gov ID
- NCT01016873
- Acronym / sponsor ID
- INTREPID / CLH002
- Conditions
- AMD, Wet AMD, Age-Related Macular Degeneration, Wet Age-Related Macular Degeneration, Macular Degeneration, Eye Diseases
- Keywords
- Oraya, Oraya Therapeutics, Inc., low voltage stereotactic radiotherapy, radiotherapy, IRay, Ranibizumab, Lucentis, AMD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- Oraya Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2009
- Primary completion
- May 2012 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 20 Nov 2009 (estimated)
- Results
- Posted 5 Dec 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 16 Gy IRay | Experimental | Device: IRay16 Gy IRay + PRN Lucentis® |
| Sham 16 Gy IRay | Sham comparator | Device: IRaySham 16 Gy IRay + PRN Lucentis® |
| 24 Gy IRay | Experimental | Device: IRay24 Gy IRay + PRN Lucentis® |
| Sham 24 Gy IRay | Sham comparator | Device: IRaySham 24 Gy IRay + PRN Lucentis® |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IRayLow voltage stereotactic radiotherapy system | Device | 16 Gy IRay, 24 Gy IRay, Sham 16 Gy IRay, Sham 24 Gy IRay |
Primary outcome
Number of Lucentis® Injections Up To And Including Week 52
Time frame: During the first 52 weeks.
7 secondary outcomes
Change in Mean Visual Acuity (VA)
Time frame: Weeks 12, 28, 52 and 104.
Percentage (Pct.) of Patients (Pts.) Losing < 15 Letters of Best Correct Visual Acuity (BCVA) From Baseline (Base.)
Time frame: Weeks 12, 28 and 52.
Percentage (Pct.) of Patients (Pts.) Gaining ≥ 15 Letters of Best Correct Visual Acuity (BCVA) From Baseline (Base.)
Time frame: Weeks 12, 28 and 52.
Percentage (Pct.) of Patients (Pts.) Gaining ≥ 0 Letters of Best Correct Visual Acuity (BCVA) From Baseline (Base.)
Time frame: Weeks 12, 28 and 52.
Time From Mandatory Injection at Day 0 to the First PRN Injection.
Time frame: 52 Weeks
Total Number (No.) of Lucentis® Injections (Inject.) During The First 12, 28, and 104 Weeks.
Time frame: Week 12, 28, and 104
Mean Change in Choroidal Neovascularization (CNV) as % of Lesion on Fluorescein Angiography (FA) From Baseline to Week 52
Time frame: Week 52
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32844399Evans 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Denis O'Shaughnessy, Ph.D. study director
Oraya Therapeutics, Inc.
21 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IRay in people with AMD and Wet AMD, run by Oraya Therapeutics, Inc. at 21 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United Kingdom, Czechia, Austria, Germany, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Dec 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Lucentis® Injections Up To And Including Week 52 (time frame: During the first 52 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01016873, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2014.