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cp-asiRNA
OLX10212 for Age-Related Macular Degeneration
Phase 1
Recruiting
Research Sponsored by Olix Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 0, day 1, day 2, and day 3 for part a and day 0, day 1, day 2, day 3, day 28, day 29, day 30, day 31,day 56, day 57, day 58, and day 59 for part b
Awards & highlights
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.
Who is the study for?
This trial is for men and women over 50 with neovascular age-related macular degeneration (AMD). Participants must have certain vision scores, a primary lesion caused by AMD, and be able to attend all visits. They can't join if they've had recent anti-VEGF therapy in either eye or other treatments that could affect the study.
What is being tested?
OLX10212, a new type of RNA-based treatment, is being tested in two parts: one where patients get a single dose and another with multiple doses. The goal is to see how safe it is and how well it works when injected into the eye of those with neovascular AMD.
What are the potential side effects?
Possible side effects are not detailed here but typically include reactions at the injection site inside the eye, increased risk of eye inflammation or infection, potential changes in vision, and any systemic effects from absorption of the drug.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 0, day 1, day 2, and day 3 for part a and day 0, day 1, day 2, day 3, day 28, day 29, day 30, day 31,day 56, day 57, day 58, and day 59 for part b
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 0, day 1, day 2, and day 3 for part a and day 0, day 1, day 2, day 3, day 28, day 29, day 30, day 31,day 56, day 57, day 58, and day 59 for part b
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Best-corrected visual acuity (BCVA)
Fluorescein angiography (FA)
Fundus examination
+3 moreOther study objectives
AUC
Cmax
Fluorescein angiography
+2 moreTrial Design
7Treatment groups
Experimental Treatment
Group I: Part B 950 μg/eye/50 μLExperimental Treatment1 Intervention
study eye treated with a total of 3 intravitreal injections of 950 μg (895.9 μg free acid) of OLX10212 each 28 days apart
Group II: Part B 750 μg/eye/50 μLExperimental Treatment1 Intervention
study eye treated with a total of 3 intravitreal injections of 750 μg (707.3 μg free acid) of OLX10212 each 28 days apart
Group III: Part A 950 μg/eye/50 μLExperimental Treatment1 Intervention
study eye treated with 950 μg (895.9 μg free acid) of OLX10212
Group IV: Part A 750 μg/eye/50 μLExperimental Treatment1 Intervention
study eye treated with 750 μg (707.3 μg free acid) of OLX10212
Group V: Part A 500 μg/eye/50 μLExperimental Treatment1 Intervention
study eye treated with 500 μg (471.5 μg free acid) of OLX10212
Group VI: Part A 250 μg/eye/50 μLExperimental Treatment1 Intervention
study eye treated with 250 μg (235.8 μg free acid) of OLX10212
Group VII: Part A 100 μg/eye/50 μLExperimental Treatment1 Intervention
study eye treated with 100 μg (94.3 μg free acid) of OLX10212
Find a Location
Who is running the clinical trial?
Olix Pharmaceuticals, Inc.Lead Sponsor
3 Previous Clinical Trials
90 Total Patients Enrolled
Trial Runners, LLCOTHER
3 Previous Clinical Trials
549 Total Patients Enrolled
Alexander Neumeister, MDStudy DirectorOlix Pharmaceuticals, Inc.
3 Previous Clinical Trials
48 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: Part A 950 μg/eye/50 μL
- Group 2: Part A 750 μg/eye/50 μL
- Group 3: Part B 750 μg/eye/50 μL
- Group 4: Part A 500 μg/eye/50 μL
- Group 5: Part B 950 μg/eye/50 μL
- Group 6: Part A 250 μg/eye/50 μL
- Group 7: Part A 100 μg/eye/50 μL
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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.
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