Age-Related Macular DegenerationPhase 2ENDEAVOURNCT01521065
An Open-label Study to Evaluate the Clinical and Economic Benefits of I-Ray in Patients With Choroidal Neovascularization Secondary to Age-related Macular Degeneration
A Phase 2 study testing IRay in people with Age-Related Macular Degeneration and Wet Macular Degeneration, run by Oraya Therapeutics, Inc. at 1 site in United Kingdom.
Trial summary
The purpose of this study is to confirm the clinical and economic benefits of IRay treatment with respect to the number of anti-VEGF injections and frequency of visits during the first year after treatment for patients with wet Age-related Macular Degeneration (AMD). Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Age-Related Macular Degeneration, Wet Macular Degeneration, Macular Degeneration
- What is being tested?
- IRay
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2012to Oct 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Must have neovascular AMD and have received an anti-VEGF injections within 1 month prior to entering the study, and have the need for further treatment with anti-VEGF therapy.
- 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 lesion perimeter.
- Must have provided informed consent, documented it in writing, and have been given a copy of the signed informed consent form.
- Must be willing and able to return for scheduled treatment and follow-up examinations for the 3-year duration of the study.
- Must be at least 50 years of age.
- Women must be post-menopausal ≥1 year or surgically sterilized.
- Must have best corrected visual acuity of greater than or equal to 24 letters in the study eye and at least 20 letters in the fellow eye (if both eyes meet all the study criteria, then the eye with the worst vision should be selected as the study eye).
Who cannot join
- Present with any implanted device, where the device labeling specifically contraindicates subjects undergoing x-rays.
- An axial length of <20 mm (because of limitations of the IRay device) or >26 mm (to exclude subjects with pathologic myopia).
- Evidence of diabetes or retinal findings consistent with diabetic retinopathy, or retinopathy for any cause.
- Prior or concurrent therapies in the study eye for age related macular degeneration (other than intravitreal anti-VEGF), including submacular surgery, subfoveal thermal laser photocoagulation (with or without photographic evidence), transpupillary thermotherapy (TTT) and ocular photodynamic therapy.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Manchester Royal Eye Hospital
Manchester, M13 9WL
Tariq Aslam, M.D., +44 771 125 0512, tariq.aslam@cmft.nhs.uk
Tariq Aslam, M.D.
About this study
Official title: A Multicenter, Open-label Study to Evaluate the Clinical and Economic Benefits of Low Voltage Stereotactic Radiotherapy in Subjects With Choroidal Neovascularization (CNV) Secondary to Age-related Macular Degeneration (AMD)
The purpose of this study is to confirm the clinical and economic benefits of IRay treatment with respect to the number of anti-VEGF injections and frequency of visits during the first year after treatment for patients with wet Age-related Macular Degeneration (AMD).
Read the detailed description
The objective of this study is to confirm the clinical and economic benefits of low voltage external beam radiotherapy with the IRay with respect to number of anti-VEGF injections and frequency of ophthalmic assessments during the one year interval following treatment in subjects with neovascular AMD.
- Conditions
- Age-Related Macular Degeneration, Wet Macular Degeneration, Macular Degeneration, Eye Diseases, Retinal Diseases
- Being tested
- IRay
- Keywords
- AMD, Wet AMD
- Medical subject headings
- Macular Degeneration, Wet 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
Approved dose of Anti-VEGF injection given at Day 0 followed by treatment with 16 Gy dose of IRay up to 14 days later.
| Study group | Role | What they receive |
|---|---|---|
| 16 Gy IRay | Experimental | 16 Gy IRay + PRN Lucentis® Receives: Device: IRay |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of anti-VEGF injections during the first 12 months
Measured: 12 Months
Secondary outcomes (3)
Time to first Anti-VEGF injection
Measured: Up to Month 12
Change in mean best-corrected visual acuity in the treated eye at month 12
Measured: Month 12
Visual Functioning Questionnaire - 25 (VFQ-25)
Measured: Baseline & Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2012 (estimated)
- Study startSep 2012
- Primary completionOct 2014 (estimated)
- Study completionOct 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age-Related Macular DegenerationStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oraya Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01521065
- Sponsor's protocol ID
- RS002
- Acronym
- ENDEAVOUR
- Status last verified
- Apr 2013
- First submitted
- 18 Jan 2012
- Last updated
- 26 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-label Study to Evaluate the Clinical and Economic Benefits of Low Voltage Stereotactic Radiotherapy in Subjects With Choroidal Neovascularization (CNV) Secondary to Age-related Macular Degeneration (AMD)
- ClinicalTrials.gov ID
- NCT01521065
- Acronym / sponsor ID
- ENDEAVOUR / RS002
- Conditions
- Age-Related Macular Degeneration, Wet Macular Degeneration, Macular Degeneration, Eye Diseases, Retinal Diseases
- Keywords
- AMD, Wet AMD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Oraya Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2012
- Primary completion
- Oct 2014 (estimated)
- Study completion
- Oct 2016 (estimated)
- First posted
- 30 Jan 2012 (estimated)
- Results
- Not posted in the source record
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 clinical and economic benefits of IRay treatment with respect to the number of anti-VEGF injections and frequency of visits during the first year after treatment for patients with wet Age-related Macular Degeneration (AMD).
Detailed description
The objective of this study is to confirm the clinical and economic benefits of low voltage external beam radiotherapy with the IRay with respect to number of anti-VEGF injections and frequency of ophthalmic assessments during the one year interval following treatment in subjects with neovascular AMD.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 16 Gy IRay | Experimental | Device: IRay16 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 (7 listed)
- Must have neovascular AMD and have received an anti-VEGF injections within 1 month prior to entering the study, and have the need for further treatment with anti-VEGF therapy.
- 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 lesion perimeter.
- Must have provided informed consent, documented it in writing, and have been given a copy of the signed informed consent form.
- Must be willing and able to return for scheduled treatment and follow-up examinations for the 3-year duration of the study.
- Must be at least 50 years of age.
Key exclusion criteria (4 listed)
- Present with any implanted device, where the device labeling specifically contraindicates subjects undergoing x-rays.
- An axial length of <20 mm (because of limitations of the IRay device) or >26 mm (to exclude subjects with pathologic myopia).
- Evidence of diabetes or retinal findings consistent with diabetic retinopathy, or retinopathy for any cause.
- Prior or concurrent therapies in the study eye for age related macular degeneration (other than intravitreal anti-VEGF), including submacular surgery, subfoveal thermal laser photocoagulation (with or without photographic evidence), transpupillary thermotherapy (TTT) and ocular photodynamic therapy.
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 |
|---|---|---|
| IRayApproved dose of Anti-VEGF injection given at Day 0 followed by treatment with 16 Gy dose of IRay up to 14 days later. | Device | 16 Gy IRay |
Primary outcome
Rate of anti-VEGF injections during the first 12 months
Time frame: 12 Months
3 secondary outcomes
Time to first Anti-VEGF injection
Time frame: Up to Month 12
Change in mean best-corrected visual acuity in the treated eye at month 12
Time frame: Month 12
Visual Functioning Questionnaire - 25 (VFQ-25)
Time frame: Baseline & Month 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2013.
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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.
1 site in 1 country: 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 Age-Related Macular Degeneration and Wet Macular Degeneration, run by Oraya Therapeutics, Inc. at 1 site in United Kingdom.
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 7 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 26 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of anti-VEGF injections during the first 12 months (time frame: 12 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Apr 2013.