Exudative Age-related Macular DegenerationPhase 1/2PBAMD2NCT01213082
ProspectiveTrial of Proton Beam Combined With Anti-VEGF Therapy for Exudative Age-related Macular Degeneration (AMD)
A Phase 1/2 study testing 24GyE proton and Anti-VEGF and 16GyE and anti-VEGF in people with Exudative Age-related Macular Degeneration, run by University of California, Davis at 1 site in United States.
Trial summary
The purpose of this study is to test the hypothesis that proton beam irradiation combined with intravitreal anti-VEGF therapy is safe and potentially more effective than intravitreal anti-VEGF therapy alone in eyes with exudative age-related macular degeneration. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Exudative Age-related Macular Degeneration
- What is being tested?
- 24GyE proton and Anti-VEGF and 16GyE and anti-VEGF
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to 31 Jan 2017
- Phase
- Phase 1/2
- 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
- Subjects will be eligible if the following criteria are met:
- Ability to provide written informed consent and comply with study assessments for the full duration of the study
- Age > 50 years
- Patient related considerations
- Able to maintain follow-up for at least 24 months.
- Women must be postmenopausal without a period for at least one year.
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- Diagnosed with Age-related Macular Degeneration (ARMD) with active subfoveal choroidal neovascular membrane (CNVM), newly diagnosed or treated with first dose of anti-VEGF therapy within 6 weeks of enrollment
- Visual acuity 20/40 to 20/400
- Lesion size < 12 Disc Area
- Submacular hemorrhage less than 75% of total lesion and not involving foveal center
- Submacular fibrosis less than 25% of total lesion
- Candidate for intravitreal anti-VEGF therapy
Who cannot join
- Subjects who meet any of the following criteria will be excluded from this study:
- Prior enrollment in the study
- Pregnancy (positive pregnancy test) or lactation
- Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated
- Participation in another simultaneous medical investigation or trial
- Previous treatment with Photodynamic Therapy (PDT) or thermal laser in study eye
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- Anti-VEGF therapy within 6 weeks
- Intravitreal or subtenon's Kenalog within 6 months
- Intraocular surgery within 3 months or expected in the next 6 months
- Current or planned participation in other experimental treatments for wet AMD
- Other concurrent retinopathy or optic neuropathy
- Other causes of CNVM, i.e. myopic degeneration or ocular histoplasmosis (POHS)
- Significant media opacity precluding adequate view of the fundus for exam, photography or OCT
- History of radiation therapy to the head or study eye
- Diabetes mellitus or hemoglobin A1c > 6
- Head tremor or h/o claustrophobia precluding positioning for proton irradiation
- Inability to maintain steady fixation with either eye
- History of Malignancy treated within 5 years
- Allergy to Fluorescein dye
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California Davis Eye Center
Sacramento, California, 95817
About this study
Official title: Phase I/II Prospective, Randomized, Double-blinded Study of Intravitreal Anti-VEGF Therapy Combined With Proton Beam Radiation Versus Sham Irradiation in Treating Exudative Age-related Macular Degeneration
The purpose of this study is to test the hypothesis that proton beam irradiation combined with intravitreal anti-VEGF therapy is safe and potentially more effective than intravitreal anti-VEGF therapy alone in eyes with exudative age-related macular degeneration.
Read the detailed description
Radiation combined with anti-VEGF therapy has been shown to be synergistic in treating cancer and result in sustained tumor regression. On-going clinical trials have shown potential synergism between intravitreal anti-VEGF therapy and epiretinal brachytherapy administered during vitrectomy surgery in treating eyes with exudative age-related macular degeneration (eAMD). In this study, we test the hypothesis that radiation to the macula administered noninvasively via proton beam is well-tolerated in eyes with eAMD when combined with intravitreal anti-VEGF therapy and that this combination therapy may act synergistically to result in sustained treatment effect in eyes with eAMD.
- Being tested
- 24GyE proton and Anti-VEGF, 16GyE and anti-VEGF, Sham Irradiation and anti-VEGF
- Keywords
- Exudative Age-related Macular Degeneration, Proton beam irradiation, ranibizumab, bevacizumab, anti-VEGF therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
24GyE proton and Anti-VEGFDrug
Also called 24Gy Proton Beam + Anti-VEGF
24GyE proton beam will be administered in 2 fractions 24 hrs apart 2 to 6 weeks after intravitreal anti-VEGF therapy
16GyE and anti-VEGFDrug
Also called 16Gy proton beam + Anti-VEGF
16GyE of Proton Beam Irradiation will be administered in 2 fractions 24 hrs apart 2 to 6 weeks after intravitreal anti-VEGF therapy
Sham Irradiation and anti-VEGFDrug
Also called Sham proton beam + anti-VEGF
2 Sessions of Sham Proton Beam Irradiation 24 hrs apart administered 2 to 6 weeks after intravitreal anti-VEGF therapy
| Study group | Role | What they receive |
|---|---|---|
| 24GyE + anti-VEGF | Experimental | Not described Receives: Drug: 24GyE proton and Anti-VEGF |
| 16GyE + anti-VEGF | Experimental | Not described Receives: Drug: 16GyE and anti-VEGF |
| Sham Irradiation + anti-VEGF | Sham comparator | Not described Receives: Drug: Sham Irradiation and anti-VEGF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of Eyes With Severe Ocular Adverse
vision loss of 3 or more lines associated with radiation retinopathy or papillopathy
Measured: Month 24
Secondary outcomes (1)
Number of Anti-VEGF Injections Administered
efficacy measure
Measured: Month 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2010 (estimated)
- Study startSep 2010
- Primary completion31 Jan 2017
- Study completion31 Jan 2017
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 Exudative Age-related Macular DegenerationStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, San Francisco
- Responsible party
- Sponsor
- Investigators
- Susanna S Park, MD PhD, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01213082
- Sponsor's protocol ID
- 223071
- Acronym
- PBAMD2
- Status last verified
- May 2018
- First submitted
- 29 Sep 2010
- Last updated
- 17 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
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 17 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Prospective, Randomized, Double-blinded Study of Intravitreal Anti-VEGF Therapy Combined With Proton Beam Radiation Versus Sham Irradiation in Treating Exudative Age-related Macular Degeneration
- ClinicalTrials.gov ID
- NCT01213082
- Acronym / sponsor ID
- PBAMD2 / 223071
- Keywords
- Exudative Age-related Macular Degeneration, Proton beam irradiation, ranibizumab, bevacizumab, anti-VEGF therapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- University of California, San Francisco
- Study start
- Sep 2010
- Primary completion
- 31 Jan 2017 (actual)
- Study completion
- 31 Jan 2017 (actual)
- First posted
- 1 Oct 2010 (estimated)
- Results
- Posted 17 Jul 2018
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 test the hypothesis that proton beam irradiation combined with intravitreal anti-VEGF therapy is safe and potentially more effective than intravitreal anti-VEGF therapy alone in eyes with exudative age-related macular degeneration.
Detailed description
Radiation combined with anti-VEGF therapy has been shown to be synergistic in treating cancer and result in sustained tumor regression. On-going clinical trials have shown potential synergism between intravitreal anti-VEGF therapy and epiretinal brachytherapy administered during vitrectomy surgery in treating eyes with exudative age-related macular degeneration (eAMD). In this study, we test the hypothesis that radiation to the macula administered noninvasively via proton beam is well-tolerated in eyes with eAMD when combined with intravitreal anti-VEGF therapy and that this combination therapy may act synergistically to result in sustained treatment effect in eyes with eAMD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 24GyE + anti-VEGF | Experimental | Drug: 24GyE proton and Anti-VEGF |
| 16GyE + anti-VEGF | Experimental | Drug: 16GyE and anti-VEGF |
| Sham Irradiation + anti-VEGF | Sham comparator | Drug: Sham Irradiation and anti-VEGF |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Subjects will be eligible if the following criteria are met:
Key exclusion criteria (19 listed)
- Subjects who meet any of the following criteria will be excluded from this study:
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 |
|---|---|---|
| 24GyE proton and Anti-VEGFAlso: 24Gy Proton Beam + Anti-VEGF24GyE proton beam will be administered in 2 fractions 24 hrs apart 2 to 6 weeks after intravitreal anti-VEGF therapy | Drug | 24GyE + anti-VEGF |
| 16GyE and anti-VEGFAlso: 16Gy proton beam + Anti-VEGF16GyE of Proton Beam Irradiation will be administered in 2 fractions 24 hrs apart 2 to 6 weeks after intravitreal anti-VEGF therapy | Drug | 16GyE + anti-VEGF |
| Sham Irradiation and anti-VEGFAlso: Sham proton beam + anti-VEGF2 Sessions of Sham Proton Beam Irradiation 24 hrs apart administered 2 to 6 weeks after intravitreal anti-VEGF therapy | Drug | Sham Irradiation + anti-VEGF |
Primary outcome
Percent of Eyes With Severe Ocular Adverse
Time frame: Month 24
vision loss of 3 or more lines associated with radiation retinopathy or papillopathy
1 secondary outcome
Number of Anti-VEGF Injections Administered
Time frame: Month 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2018.
- 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.
Susanna S Park, MD PhD principal investigator
University of California, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing 24GyE proton and Anti-VEGF and 16GyE and anti-VEGF in people with Exudative Age-related Macular Degeneration, run by University of California, Davis at 1 site in United States.
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 12 inclusion and 19 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 17 Jul 2018. 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 States. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 17 Jul 2018). 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?
Percent of Eyes With Severe Ocular Adverse (time frame: Month 24). 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 NCT01213082, 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 17 Jul 2018; AzTrials last refreshed its copy on 8 Nov 2026.