Macular DegenerationPhase 3CABERNETNCT00454389
A Study of Strontium90 Beta Radiation With Lucentis to Treat Age-Related Macular Degeneration
A Phase 3 study testing Epi-Rad90™ Ophthalmic System and ranibizumab in people with Macular Degeneration, run by NeoVista at 32 sites in 9 countries.
Trial summary
The objective of the CABERNET Trial is to evaluate the safety and efficacy of focal delivery of radiation for the treatment of subfoveal choroidal neovascularization (CNV) associated 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
- Macular Degeneration
- What is being tested?
- Epi-Rad90™ Ophthalmic System and ranibizumab
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 494 participants
- Where
- 32 sitesin 9 countries
- Study dates
- Apr 2007to Aug 2012
- Phase
- Phase 3
- 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 predominantly classic, minimally classic, or occult with no classic lesions, as determined by the Investigator, secondary to AMD, with a total lesion size (including blood, scarring, and neovascularization) of < 12 total disc areas (21.24 mm2), and a GLD ≤5.4 mm
- Subjects must be age 50 or older
Who cannot join
- Subjects with prior or concurrent subfoveal CNV therapy including thermal laser photocoagulation (with or without photographic evidence), photodynamic therapy, injections with Macugen®, intravitreal or subretinal steroids, transpupillary thermotherapy (TTT), and systemic anti-angiogenic or intravitreal anti-angiogenic agents in study eye. (Note: This includes subjects with no known history, but with photographic evidence of prior therapy)
- Subjects who underwent previous radiation therapy to the eye, head or neck
- Subjects that have been previously diagnosed or have retinal findings consistent with Type 1 or Type 2 Diabetes Mellitus
Trial locations and contacts
32 sites in 9 countries.
32 sites in 9 countries
United States23 sites
Southeast Retina Center
Augusta, Georgia, 30909
Austin Retina Associates
Austin, Texas, 78705
Retina Research Center
Austin, Texas, 78705
Retina-Vitreous Associates Medical
Beverly Hills, California, 90211
New England Eye Center-Tufts University
Boston, Massachusetts, 02111
Retinal Diagnostic Center
Campbell, California, 95008
Charlotte Eye Ear Nose & Throat Associates
Charlotte, North Carolina, 28210
Cincinnati Eye Institute
Cincinnati, Ohio, 45242
Retina Group of Florida
Fort Lauderdale, Florida, 33334
Retina Institute of Hawaii
Honolulu, Hawaii, 96814
Eye Foundation of Kansas City
Kansas City, Missouri, 64108
University of Wisconsin
Madison, Wisconsin, 53705
Northern California Retina Vitreous Associates
Mountain View, California, 94040
Tennessee Retina
Nashville, Tennessee, 37203
Paducah Retinal Center
Paducah, Kentucky, 42001
Retina Research Unit of Wills Eye Hospital
Philadelphia, Pennsylvania, 19107
Retinal Consultants of Arizona
Phoenix, Arizona, 85014
Associated Retinal Consultants / William Beaumont Hospital
Royal Oak, Michigan, 48073
Rocky Mountain Retina Consultants
Salt Lake City, Utah, 84107
Medical Center Ophthalmology Associates
San Antonio, Texas, 78240
Retina & Uveitis Consultants of Texas
San Antonio, Texas, 78240
UCSF Koret Vision Center
San Francisco, California, 94143
Retina Center, PC
Tucson, Arizona, 85704
Germany2 sites
Klinik und Poliklinik für Augenheilkunde der Universität Leipzig AöR
Leipzig, 04103
Universitätsklinik und polyklinik für Augenkranke
Würzburg, 97080
Ireland1 site
Institute of Clinical Science, Ophthalmic Research Centre, Royal Victoria Hospital
Belfast
About this study
Official title: A Randomized, Prospective, Active Controlled, Study of the Epi-Rad90™ Ophthalmic System for the Treatment of Subfoveal Choroidal Neovascularization Associated With Wet Age-Related Macular Degeneration
The objective of the CABERNET Trial is to evaluate the safety and efficacy of focal delivery of radiation for the treatment of subfoveal choroidal neovascularization (CNV) associated with wet age-related macular degeneration (AMD). The Epi-Rad90™ Ophthalmic System treats neovascularization of retinal tissue by means of a focal, directional delivery of radiation to the target tissues in the retina. Using standard vitreoretinal surgical techniques, the sealed radiation source is placed temporarily over the retinal lesion by means of a handheld medical device.
Read the detailed description
Therapeutic advances in the arena of neovascular age-related macular degeneration (AMD) have provided multiple treatment options for the disease. Radiotherapy has been studied in multiple clinical trials in the past with many studies showing a therapeutic benefit. Treatment with radiotherapy and anti-VEGF compounds is a promising approach to treating AMD.
- Conditions
- Macular Degeneration
- Being tested
- Epi-Rad90™ Ophthalmic System, ranibizumab
- Keywords
- Macular, Degeneration, AMD, Wet Age-Related macular degeneration
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epi-Rad90™ Ophthalmic SystemDevice
A single procedure using the Epi-Rad90™ Ophthalmic System plus 2 injections of Lucentis administered 1 month apart
ranibizumabDrug
Also called Lucentis
Lucentis injection administered monthly for the first 3 injections followed by quarterly injections
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Epi-Rad90™ Ophthalmic System procedure + Lucentis Receives: Device: Epi-Rad90™ Ophthalmic System |
| B | Active comparator | Lucentis only Receives: Drug: ranibizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of subjects losing fewer than 15 letters of best corrected visual acuity score at 12 months compared to baseline. Gain of 15 more letters of best correct visual acuity score compared to baseline
Measured: 12 months
Secondary outcomes (5)
No loss in ETDRS letters
Measured: 12 months
Change in total lesion size and CNV size by fluorescein angiography
Measured: 12 months
Number of rescue injections of Lucentis.
Measured: 12 months
Mean change in ETDRS visual acuity
Measured: 12 months
Incidence and severity of adverse events and ocular adverse events. Incidence of cataract changes. Incidents of radiation induced toxicity.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2007 (estimated)
- Study startApr 2007
- Primary completionSep 2011 (estimated)
- Study completionAug 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 494 participants (actual)
Sponsor and investigators
- Lead sponsor
- NeoVista
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pravin Dugel, MD, Principal investigator, Retinal Consultants of ArizonaJeffrey A Nau, MMS, Study director, NeoVista, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00454389
- Sponsor's protocol ID
- NVI-114
- Acronym
- CABERNET
- Status last verified
- Jul 2011
- First submitted
- 28 Mar 2007
- Last updated
- 27 Jul 2011
- Results posted
- No
- 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 27 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Prospective, Active Controlled, Study of the Epi-Rad90™ Ophthalmic System for the Treatment of Subfoveal Choroidal Neovascularization Associated With Wet Age-Related Macular Degeneration
- ClinicalTrials.gov ID
- NCT00454389
- Acronym / sponsor ID
- CABERNET / NVI-114
- Conditions
- Macular Degeneration
- Keywords
- Macular, Degeneration, AMD, Wet Age-Related macular degeneration
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 494 participants (actual)
- Lead sponsor
- NeoVistaIndustry (pharma, biotech, devices)
- Study start
- Apr 2007
- Primary completion
- Sep 2011 (estimated)
- Study completion
- Aug 2012 (estimated)
- First posted
- 30 Mar 2007 (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 the CABERNET Trial is to evaluate the safety and efficacy of focal delivery of radiation for the treatment of subfoveal choroidal neovascularization (CNV) associated with wet age-related macular degeneration (AMD). The Epi-Rad90™ Ophthalmic System treats neovascularization of retinal tissue by means of a focal, directional delivery of radiation to the target tissues in the retina. Using standard vitreoretinal surgical techniques, the sealed radiation source is placed temporarily over the retinal lesion by means of a handheld medical device.
Detailed description
Therapeutic advances in the arena of neovascular age-related macular degeneration (AMD) have provided multiple treatment options for the disease. Radiotherapy has been studied in multiple clinical trials in the past with many studies showing a therapeutic benefit. Treatment with radiotherapy and anti-VEGF compounds is a promising approach to treating AMD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Device: Epi-Rad90™ Ophthalmic SystemEpi-Rad90™ Ophthalmic System procedure + Lucentis |
| B | Active comparator | Drug: ranibizumabLucentis only |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects must have predominantly classic, minimally classic, or occult with no classic lesions, as determined by the Investigator, secondary to AMD, with a total lesion size (including blood, scarring, and neovascularization) of < 12 total disc areas (21.24 mm2), and a GLD ≤5.4 mm
- Subjects must be age 50 or older
Key exclusion criteria (3 listed)
- Subjects with prior or concurrent subfoveal CNV therapy including thermal laser photocoagulation (with or without photographic evidence), photodynamic therapy, injections with Macugen®, intravitreal or subretinal steroids, transpupillary thermotherapy (TTT), and systemic anti-angiogenic or intravitreal anti-angiogenic agents in study eye. (Note: This includes subjects with no known history, but with photographic evidence of prior therapy)
- Subjects who underwent previous radiation therapy to the eye, head or neck
- Subjects that have been previously diagnosed or have retinal findings consistent with Type 1 or Type 2 Diabetes Mellitus
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 |
|---|---|---|
| Epi-Rad90™ Ophthalmic SystemA single procedure using the Epi-Rad90™ Ophthalmic System plus 2 injections of Lucentis administered 1 month apart | Device | A |
| ranibizumabAlso: LucentisLucentis injection administered monthly for the first 3 injections followed by quarterly injections | Drug | B |
Primary outcome
Percentage of subjects losing fewer than 15 letters of best corrected visual acuity score at 12 months compared to baseline. Gain of 15 more letters of best correct visual acuity score compared to baseline
Time frame: 12 months
5 secondary outcomes
No loss in ETDRS letters
Time frame: 12 months
Change in total lesion size and CNV size by fluorescein angiography
Time frame: 12 months
Number of rescue injections of Lucentis.
Time frame: 12 months
Mean change in ETDRS visual acuity
Time frame: 12 months
Incidence and severity of adverse events and ocular adverse events. Incidence of cataract changes. Incidents of radiation induced toxicity.
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2011.
- 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.
Pravin Dugel, MD principal investigator
Retinal Consultants of Arizona
Jeffrey A Nau, MMS study director
NeoVista, Inc.
32 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Epi-Rad90™ Ophthalmic System and ranibizumab in people with Macular Degeneration, run by NeoVista at 32 sites in 9 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 2 inclusion and 3 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 27 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in United States, Germany, Austria, Ireland, Israel and 4 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
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?
Percentage of subjects losing fewer than 15 letters of best corrected visual acuity score at 12 months compared to baseline. Gain of 15 more letters of best correct visual acuity score compared to baseline (time frame: 12 months). 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 NCT00454389, 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 27 Jul 2011.