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OLX10212 for Age-Related Macular Degeneration
Study Summary
This trial studies the safety, tolerability, efficacy, and pharmacokinetics of a drug for neovascular age-related macular degeneration. It will look at single and multiple doses.
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Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- I haven't had an eye infection in the last 2 weeks.More than half of the lesion in my eye is scarred or has fibrosis.I am 50 years old or older.I haven't received anti-VEGF therapy in my eye within the last 4 weeks.I have had a tear in the retina of my study eye within the last 6 months.I have or had eye inflammation or uveitis.I haven't received any experimental treatments for AMD in my study eye within the last 6 months.My glaucoma is not controlled even with medication.I haven't taken any VEGF inhibitors in the last 3 months.I haven't had bleeding inside my eye in the last 4 weeks.I have had or will have radiation therapy near my study eye.My eyes can be dilated enough for clear pictures to be taken.I am willing and able to attend all clinic visits and complete study procedures.My eye's macular region is thickened and I have active wet AMD according to my doctor.I have not used systemic treatments for AMD, except for vitamins or anti-VEGF therapy.My eye has a condition called scleromalacia.My eye did not respond to previous anti-VEGF treatment.I haven't been in a clinical study or taken experimental treatments in the last 12 weeks.My eye condition is due to AMD and affects the center of my vision.I am treating my glaucoma with 3 or more medications.I have severe eye problems due to diabetes or other blood vessel issues, not including AMD.I haven't used long-acting steroids in the last 6 months and don't plan to use them during the study.My study eye is missing its natural lens or has no back part of the lens capsule, not due to YAG laser surgery.My study eye has had a macular hole of stage 2 or higher.I have been treated with anti-VEGF medication before.My eye condition is not due to high myopia, infections, or other specific eye diseases.I haven't used experimental eye treatments in the last 3 months, except bevacizumab.I don't have any health issues that could interfere with the study or increase my risk of complications.My eye condition won't need surgery or affect the study's safety and results.I haven't had eye surgery recently, except for eyelid surgery over a month ago.I am using or willing to use effective birth control if I can become pregnant.
- Group 1: Part B 950 μg/eye/50 μL
- Group 2: Part A 500 μg/eye/50 μL
- Group 3: Part A 750 μg/eye/50 μL
- Group 4: Part A 950 μg/eye/50 μL
- Group 5: Part B 750 μg/eye/50 μL
- Group 6: Part A 250 μg/eye/50 μL
- Group 7: Part A 100 μg/eye/50 μL
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What adverse effects may result from application of Part A 1650.3 μg/eye?
"At this time, there is limited clinical data attesting to the safety and efficacy of Part A 1650.3 μg/eye, consequently receiving a score of 1."
Are there multiple healthcare facilities offering this trial in the area?
"Currently, this study is recruiting from Texas Retina Consultants in Bellaire, The Retina Institute in Saint Louis, and California Retina Consultants in Santa Maria. There are 5 additional sites involved as well."
Is enrollment in this experiment still open?
"Indeed, the records on clinicaltrials.gov suggest that this medical trial is actively recruiting patients. This study was initially published on December 1st 2022 and underwent a revision of its details most recently also in December 1st 2022. A total of 60 people will be accepted from 5 different sites."
How many subjects are receiving treatment as part of this research project?
"The successful execution of this trial requires 60 eligible participants. Olix Pharmaceuticals Inc., the sponsor, will be conducting the study from two locations: Texas Retina Consultants in Bellaire and The Retina Institute in Saint Louis."
Who else is applying?
What state do they live in?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
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