Age-related Macular DegenerationEarly Phase 1NCT00517010
Pilot Study of Lucentis Combined With Proton Beam Irradiation in Treating Wet Age-related Macular Degeneration
A Early Phase 1 study testing Proton beam irradiation and ranibizumab in people with Age-related Macular Degeneration, run by University of California, Davis.
Trial summary
Because a possible synergism of radiation and inhibitors of vascular endothelial growth factor has been shown in cancer patients and patients with wet macular degeneration, this pilot study is being conducted to determine whether treating wet macular degeneration with a combination of Lucentis and proton beam… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Age-related Macular Degeneration
- What is being tested?
- Proton beam irradiation and ranibizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- No sites listed yet
- Study dates
- May 2007to Jun 2010
- Phase
- Early Phase 1
- 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
- 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.
- Hgb A1C < 6
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- Diagnosed with Age-related Macular Degeneration (ARMD) with active subfoveal choroidal neovascular membrane (CNVM), new or recurrent
- Visual acuity 20/60 to 20/400
- Lesion size < 12 Disc Area
- Submacular hemorrhage less than 75% of total lesion
- Submacular fibrosis less than 25% of total lesion
- Candidate for intravitreal Lucentis
Who cannot join
- 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
- CNVM within 1 mm from the disc margin
- Photodynamic Therapy (PDT) within 3 months
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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
- Systemic anticoagulation with coumadin
- Head tremor or h/o claustrophobia precluding positioning for proton irradiation
- Inability to maintain steady fixation with either eye
- Diabetes mellitus requiring treatment
- History of Malignancy treated within 5 years
- Allergy to Fluorescein dye
About this study
Official title: Phase 1 Pilot Open Label Prospective Observational Study of Safety and Tolerability of Lucentis Combined With Proton Beam Irradiation in Treating Exudative Age-related Macular Degeneration
Because a possible synergism of radiation and inhibitors of vascular endothelial growth factor has been shown in cancer patients and patients with wet macular degeneration, this pilot study is being conducted to determine whether treating wet macular degeneration with a combination of Lucentis and proton beam irradiation is safe. Lucentis is an inhibitor of vascular endothelial growth factor which was recently FDA approved for treatment of wet macular degeneration. It appears to be the most effective therapy thus far for wet macular degeneration among all drugs FDA approved for this condition. If no major safety issues are associated with this combination therapy, a larger study will be conducted to determine whether this combination therapy is more effective than Lucentis monotherapy.
Read the detailed description
Five subjects diagnosed with wet macular degeneration will be treated with standard of care, i.e. intravitreal Lucentis injection monthly for the first four months and as needed thereafter. Within six weeks of the first Lucentis injection, the eye will also be treated with 24 Gy of proton beam divided into two fractions. Each subject will be followed for 2 yrs with monthly examination.
- Conditions
- Age-related Macular Degeneration
- Being tested
- Proton beam irradiation and ranibizumab
- Keywords
- Age-related macular degeneration, Exudative age-related macular degeneration, Wet macular degeneration, Intravitreal injection, Proton beam irradiation, Lucentis, Ranibizumab
- Medical subject headings
- Macular Degeneration, Wet Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proton beam irradiation and ranibizumabDrug
Also called Lucentis and proton beam
ranibizumab 0.5mg intravitreal monthly x 4, then prn combined with low dose proton beam irradiation 24Gy (2 fractions, 24 hours apart) during the first month of study.
| Study group | Role | What they receive |
|---|---|---|
| proton beam with ranibizumab | Experimental | Intervention is 24Gy proton radiation in 2 fractions given within 6 weeks of first dose of intravitreal ranibizumab (0.5mg) drug combined with four monthly doses of intravitreal lucentis and monthly prn lucentis thereafter. Receives: Drug: Proton beam irradiation and ranibizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and Severity of Ocular Adverse Events
Any ocular adverse event identified by eye examination during the study follow-up will be recorded and determined for possible or probable relation to study treatment.
Measured: 24 months
Secondary outcomes (1)
1. Change in BCVA From Baseline
change in number of letter read correctly in study eye compared to the number of letters read correctly at baseline, i.e. BCVA (number of letters read correctly) at 24 months minus BCVA (number of letters read correctly) at baseline
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2007 (estimated)
- Study startMay 2007
- Primary completionJun 2010
- Study completionJun 2010
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 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, San Francisco, Genentech, Inc.
- Responsible party
- Sponsor
- Investigators
- Susanna S Park, MD PhD, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00517010
- Sponsor's protocol ID
- 200715285
- Other IDs
- 100,481
- Status last verified
- Jun 2016
- First submitted
- 15 Aug 2007
- Last updated
- 11 Jul 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: Findings have been presented at national and international venues and published in scientific peer-reviewed journal
Publications
Park SS, Daftari I, Phillips T, Morse LS. Three-year follow-up of a pilot study of ranibizumab combined with proton beam irradiation as treatment for exudative age-related macular degeneration. Retina. 2012 May;32(5):956-66. doi: 10.1097/IAE.0b013e31822a8d6a.
PubMed 22183743
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Pilot Open Label Prospective Observational Study of Safety and Tolerability of Lucentis Combined With Proton Beam Irradiation in Treating Exudative Age-related Macular Degeneration
- ClinicalTrials.gov ID
- NCT00517010
- Acronym / sponsor ID
- 200715285
- Conditions
- Age-related Macular Degeneration
- Keywords
- Age-related macular degeneration, Exudative age-related macular degeneration, Wet macular degeneration, Intravitreal injection, Proton beam irradiation, Lucentis, Ranibizumab
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- University of California, San Francisco, Genentech, Inc.
- Study start
- May 2007
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 16 Aug 2007 (estimated)
- Results
- Posted 11 Jul 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Because a possible synergism of radiation and inhibitors of vascular endothelial growth factor has been shown in cancer patients and patients with wet macular degeneration, this pilot study is being conducted to determine whether treating wet macular degeneration with a combination of Lucentis and proton beam irradiation is safe. Lucentis is an inhibitor of vascular endothelial growth factor which was recently FDA approved for treatment of wet macular degeneration. It appears to be the most effective therapy thus far for wet macular degeneration among all drugs FDA approved for this condition. If no major safety issues are associated with this combination therapy, a larger study will be conducted to determine whether this combination therapy is more effective than Lucentis monotherapy.
Detailed description
Five subjects diagnosed with wet macular degeneration will be treated with standard of care, i.e. intravitreal Lucentis injection monthly for the first four months and as needed thereafter. Within six weeks of the first Lucentis injection, the eye will also be treated with 24 Gy of proton beam divided into two fractions. Each subject will be followed for 2 yrs with monthly examination.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| proton beam with ranibizumab | Experimental | Drug: Proton beam irradiation and ranibizumabIntervention is 24Gy proton radiation in 2 fractions given within 6 weeks of first dose of intravitreal ranibizumab (0.5mg) drug combined with four monthly doses of intravitreal lucentis and monthly prn lucentis thereafter. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (21 listed)
- 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
- CNVM within 1 mm from the disc margin
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 |
|---|---|---|
| Proton beam irradiation and ranibizumabAlso: Lucentis and proton beamranibizumab 0.5mg intravitreal monthly x 4, then prn combined with low dose proton beam irradiation 24Gy (2 fractions, 24 hours apart) during the first month of study. | Drug | proton beam with ranibizumab |
Primary outcome
Incidence and Severity of Ocular Adverse Events
Time frame: 24 months
Any ocular adverse event identified by eye examination during the study follow-up will be recorded and determined for possible or probable relation to study treatment.
1 secondary outcome
1. Change in BCVA From Baseline
Time frame: 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 22183743Park SS, Daftari I, Phillips T, Morse LS. Three-year follow-up of a pilot study of ranibizumab combined with proton beam irradiation as treatment for exudative age-related macular degeneration. Retina. 2012 May;32(5):956-66. doi: 10.1097/IAE.0b013e31822a8d6a.
- Individual participant dataSharing planned: Yes. Findings have been presented at national and international venues and published in scientific peer-reviewed journal
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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
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Proton beam irradiation and ranibizumab in people with Age-related Macular Degeneration, run by University of California, Davis.
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 21 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 11 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 11 Jul 2016). 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?
Incidence and Severity of Ocular Adverse Events (time frame: 24 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 NCT00517010, 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 11 Jul 2016.