CompletedPhase 1/2

Prophylactic Ranibizumab for Exudative Age-related Macular Degeneration

United States108 participantsStarted 2014-09-17

Plain-language summary

This study will determine whether quarterly injections of Ranibizumab may prevent eyes with dry age-related macular degeneration from progressing to wet age-related macular degeneration (AMD).

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: * Adult over 50 years old * Able to sign informed consent and comply with the study protocol for the duration of two years * Nonexudative age-related macular degeneration (AMD) in one eye (study eye) * History of exudative AMD in one eye only (fellow eye) diagnosed within 5 years of study enrollment Exclusion Criteria: * Participation in another simultaneous medical investigation or clinical trial * Patient is pregnant, lactating, or premenopausal and not using adequate contraception * Known serious allergies to ranibizumab, fluorescein dye, drugs for pupillary dilation, topical anesthetic, sterilizing solution (e.g. Betadine solution) * Presence of ocular conditions with increased risk of choroidal neovascularization (CNVM) or pigment epithelial detachment (PED), including presumed ocular histoplasmosis syndrome (POHS), traumatic choroidal rupture, angioid streaks, pathologic myopia (spherical equivalent of ≥ -8 diopters or axial length of ≥ 25 mm), multifocal choroiditis, macular choroidal nevus, polypoidal choroidal vasculopathy (PCV), idiopathic central serous chorioretinopathy (ICSC), etc. * History of vitrectomy in the study eye * History of cataract surgery within 3 months of enrollment * History of yttrium aluminum garnet (YAG) capsulotomy within 1 month of enrollment * History of intraocular or periocular corticosteroid therapy within the past 90 days * History of therapeutic radiation in the region of the study eye. * Presence of media opacity…

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

Development of exudative AMD

Timeframe: 2 years

Trial details

NCT IDNCT02140151

SponsorSouthern California Desert Retina Consultants, MC

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-07-09

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

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.