Wet Age-related Macular DegenerationNCT01339949
Study to Evaluate the Safety and Effectiveness of IRay in Wet Age-related Macular Degeneration (AMD) Patients With Recurrent Leakage Secondary to Choroidal Neovascularisation (CNV)
A study testing IRay in people with Wet Age-related Macular Degeneration and Age-related Macular Degeneration, run by Oraya Therapeutics, Inc. at 3 sites in 2 countries.
Trial summary
The objective of this study is to confirm the safety and to establish the effectiveness of low voltage external beam radiosurgery using the IRay System for the treatment of subjects with recurrent leakage secondary to neovascular Age-related Macular Degeneration (AMD) as determined by decreasing the number of Lucentis… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Wet Age-related Macular Degeneration, Age-related Macular Degeneration, AMD
- 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
- 0 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Jun 2011to Oct 2014
- Phase
- Interventional
- 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
- Subjects must have neovascular AMD, have received at least 6 prior injections with Lucentis or Avastin and have exhibited one or more of the following:
- have persisting fluid despite 3 consecutive monthly injections of anti- VEGF, or
- received 4 prior injections over a 6 month period, or
- received 8 prior injections over a 12 month period.
- Subjects must now have the need for further anti-VEGF treatment due to increased fluid or persistent cysts on OCT, or leakage on FA.
- Subjects 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.
Show all 10Show fewer
- Subjects must have signed (and been given) a copy of the informed consent form, and be willing and able to return for scheduled treatment and follow-up examinations for the 3-year duration of the study.
- Subjects 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.
- Subjects 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).
- A globe axial length of <20 mm or >26 mm.
- Evidence of uncontrolled diabetes as determined by an HbA1c of >6.5% and/or 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), or ocular photodynamic therapy in the study eye.
- History of radiation to the head in the region of the study eye.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United Kingdom2 sites
King's College Hospital
London
Manchester Royal Eye Hospital
Manchester
About this study
Official title: A Double-masked, Sham Controlled, Study to Evaluate the Safety and Effectiveness of Low Voltage Stereotactic Radiosurgery in Wet AMD Patients With Recurrent Leakage Secondary to CNV
The objective of this study is to confirm the safety and to establish the effectiveness of low voltage external beam radiosurgery using the IRay System for the treatment of subjects with recurrent leakage secondary to neovascular Age-related Macular Degeneration (AMD) as determined by decreasing the number of Lucentis injections required during the first 12 months of the study.
Read the detailed description
The objective of this study is to confirm the safety and to establish the effectiveness of low voltage external beam radiosurgery using the IRay System for the treatment of subjects with recurrent leakage secondary to neovascular AMD as determined by decreasing the number of Lucentis injections required during the first 12 months of the study.
- Conditions
- Wet Age-related Macular Degeneration, Age-related Macular Degeneration, AMD, Wet AMD, Macular Degeneration
- Being tested
- IRay
- Keywords
- AMD, wet AMD, Macular Degeneration, wet Age-related Macular Degeneration, Age-Related Macular Degeneration, IRay, radiation, Oraya, Oraya Therapeutics, Inc, Low-voltage stereotactic radiosurgery, radiosurgery, x-ray, Lucentis, external beam radiation
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IRayDevice
low voltage external beam radiosurgery
IRayDevice
low voltage external beam radiosurgery
| Study group | Role | What they receive |
|---|---|---|
| 24 Gy radiation | Experimental | Not described Receives: Device: IRay |
| Sham 24 Gy radiation | Sham comparator | Not described Receives: Device: IRay |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Lucentis injections during first 52 weeks
Measured: 52 weeks
Secondary outcomes (2)
Change in mean VA
Measured: 52 weeks
Loss/gain of letters of BCVA
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 posted21 Apr 2011 (estimated)
- Study startJun 2011
- Primary completionOct 2012 (estimated)
- Study completionOct 2014 (estimated)
Why it stopped: Sponsor decision to withdraw study to pursue others.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wet 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oraya Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01339949
- Sponsor's protocol ID
- CLH005
- Status last verified
- Dec 2011
- First submitted
- 20 Apr 2011
- Last updated
- 30 Dec 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-masked, Sham Controlled, Study to Evaluate the Safety and Effectiveness of Low Voltage Stereotactic Radiosurgery in Wet AMD Patients With Recurrent Leakage Secondary to CNV
- ClinicalTrials.gov ID
- NCT01339949
- Acronym / sponsor ID
- CLH005
- Conditions
- Wet Age-related Macular Degeneration, Age-related Macular Degeneration, AMD, Wet AMD, Macular Degeneration
- Keywords
- AMD, wet AMD, Macular Degeneration, wet Age-related Macular Degeneration, Age-Related Macular Degeneration, IRay, radiation, Oraya
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor decision to withdraw study to pursue others.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Oraya Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2011
- Primary completion
- Oct 2012 (estimated)
- Study completion
- Oct 2014 (estimated)
- First posted
- 21 Apr 2011 (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 objective of this study is to confirm the safety and to establish the effectiveness of low voltage external beam radiosurgery using the IRay System for the treatment of subjects with recurrent leakage secondary to neovascular Age-related Macular Degeneration (AMD) as determined by decreasing the number of Lucentis injections required during the first 12 months of the study.
Detailed description
The objective of this study is to confirm the safety and to establish the effectiveness of low voltage external beam radiosurgery using the IRay System for the treatment of subjects with recurrent leakage secondary to neovascular AMD as determined by decreasing the number of Lucentis injections required during the first 12 months of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 24 Gy radiation | Experimental | Device: IRay |
| Sham 24 Gy radiation | Sham comparator | Device: IRay |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Subjects must have neovascular AMD, have received at least 6 prior injections with Lucentis or Avastin and have exhibited one or more of the following:
- Subjects must now have the need for further anti-VEGF treatment due to increased fluid or persistent cysts on OCT, or leakage on FA.
- Subjects 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.
- Subjects must have signed (and been given) a copy of the informed consent form, and be willing and able to return for scheduled treatment and follow-up examinations for the 3-year duration of the study.
- Subjects must be at least 50 years of age.
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).
- A globe axial length of <20 mm or >26 mm.
- Evidence of uncontrolled diabetes as determined by an HbA1c of >6.5% and/or 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), or ocular photodynamic therapy in the study eye.
- History of radiation to the head in the region of the study eye.
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 external beam radiosurgery | Device | 24 Gy radiation |
| IRaylow voltage external beam radiosurgery | Device | Sham 24 Gy radiation |
Primary outcome
Number of Lucentis injections during first 52 weeks
Time frame: 52 weeks
2 secondary outcomes
Change in mean VA
Time frame: 52 weeks
Loss/gain of letters of BCVA
Time frame: week 52
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2011.
Related trials for Wet Age-related Macular Degeneration
Active, not recruitingObservational study
Retinal Pigment Epithelium Safety Study For Patients In B4711001
Age Related Macular Degeneration
Active, not recruitingPhase 3
A Study to Evaluate the Efficacy and Safety of Tarcocimab Tedromer and Tabirafusp Tedromer Compared to Aflibercept in Participants With Neovascular (Wet) Age-related Macular Degeneration (wAMD) - DAYBREAK
Wet Age-related Macular Degeneration
Not yet recruitingPhase 2
A Study to Evaluate the Efficacy and Safety of VIS-101 in Participants With Neovascular Age-Related Macular Degeneration
Neovascular Age Related Macular Degeneration(nAMD)
RecruitingPhase 1
Safety and Efficacy Study of IVB103 Injection in Subjects With Neovascular (Wet) Agerelated Macular Degeneration (nAMD).
nAMD
RecruitingPhase 2
Safety and Efficacy of AIV007 Periocular Injection in Patients With Neovascular Age-Related Macular Degeneration
Neovascular (Wet) Age-Related Macular Degeneration
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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IRay in people with Wet Age-related Macular Degeneration and Age-related Macular Degeneration, run by Oraya Therapeutics, Inc. at 3 sites in 2 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 10 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: withdrawn, as of the sponsor's last update on 30 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom, 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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 during first 52 weeks (time frame: 52 weeks). 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 30 Dec 2011.