CompletedEarly Phase 1

Pilot Study of Lucentis Combined With Proton Beam Irradiation in Treating Wet Age-related Macular Degeneration

6 participantsStarted 2007-05

Plain-language 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 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.

Who can participate

Age range

50 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 * 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 Exclusion Criteria: * 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 * 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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence and Severity of Ocular Adverse Events

Timeframe: 24 months

Trial details

NCT IDNCT00517010

SponsorUniversity of California, Davis

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2010-06

Results submitted2015-12-02

View on ClinicalTrials.gov More Age-related Macular Degeneration trials