Your session is about to expire
← Back to Search
Corticosteroid
Dexamethasone IVT Implant for Eye Swelling Conditions
Phase 2
Waitlist Available
Led By Jagjit Gilhotra
Research Sponsored by Ripple Therapeutics Pty Ltd
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
A diagnosis of CRVO, BRVO, or HRVO with specific retinal and macular criteria
Age ≥ 45 years at the time of informed consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measurements from baseline to 6 months (24 weeks)
Awards & highlights
Study Summary
This trial tests if an IVT Dexamethasone Implant is safe and effective for DMO & RVO patients. Assessors are masked for dosage.
Who is the study for?
This trial is for adults over 45 with diabetes and specific retinal conditions like CRVO, BRVO, or HRVO. They must have certain visual acuity and retinal thickness, agree to use double-barrier contraception, and be able to consent. Excluded are those allergic to corticosteroids, with recent intensive insulin treatment or uncontrolled blood pressure, very high HbA1c levels (>12%), severe kidney issues, recent serious heart problems, pregnant women or those planning pregnancy within 24 months.Check my eligibility
What is being tested?
The trial tests two doses of IBE-814 IVT Dexamethasone Implant (70ug and 140ug) in patients with Diabetic Macular Edema (DMO) and Retinal Vein Occlusion (RVO). It's a phase II study where the safety assessors don't know which dose participants receive but aim to find out which dosage works better for reducing swelling in the retina.See study design
What are the potential side effects?
Potential side effects may include increased eye pressure especially if there's a history of steroid-induced eye pressure elevation. Other common risks associated with intravitreal implants like infection or inflammation inside the eye could also occur.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with a specific type of retinal vein occlusion.
Select...
I am 45 years old or older.
Select...
I have diabetes with specific eye conditions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ measurements from baseline to 6 months (24 weeks)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measurements from baseline to 6 months (24 weeks)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Adverse Events
Best Corrected Visual Acuity
Central Subfield Thickness
+4 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Low doseExperimental Treatment1 Intervention
One (1) IBE-814 IVT Implant (70 μg Dexamethasone) Route of administration: intravitreal injections
Group II: High doseExperimental Treatment1 Intervention
Two (2) IBE-814 IVT Implant (140 μg Dexamethasone) Route of administration: intravitreal injections
Find a Location
Who is running the clinical trial?
Novotech (Australia) Pty LimitedIndustry Sponsor
68 Previous Clinical Trials
7,362 Total Patients Enrolled
Ripple Therapeutics Pty LtdLead Sponsor
Jagjit GilhotraPrincipal InvestigatorRoyal Adelaide Hospital
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't taken steroids in the last 4 months and don't plan to during the study.I have been diagnosed with a specific type of retinal vein occlusion.I am 45 years old or older.My study eye meets the specific vision, thickness, and treatment history requirements.I have diabetes with specific eye conditions.I have not had a recent heart attack or worsening heart failure.My study eye does not have any excluded conditions or past treatments.I started or plan to start intensive insulin treatment recently.I have or might have an eye infection.I am allergic to corticosteroids or ingredients in the study treatment.My eye pressure once increased to ≥30 mmHg due to steroids.My blood pressure is not under control.You plan to move away from the study center area to a place that doesn't have another study center within 18 months.Your blood test shows a level of HbA1c higher than 12.0%.I have chronic kidney failure and need dialysis or have had a kidney transplant.
Research Study Groups:
This trial has the following groups:- Group 1: High dose
- Group 2: Low dose
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many geographical areas are hosting this research endeavour?
"This clinical trial provides 23 different possible sites for recruitment, including Eye Doctors Mona Vale in Mona Vale, Marsden Eye Specialist in Parramatta and Sydney Eye Hospital in Sydney."
Answered by AI
Has the Federal Drug Administration approved a high dosage of this medication?
"The safety of high dose treatment has been assessed and given a score of 2 due to the fact that there is only preliminary data validating its protection, but no proof yet of it being efficacious."
Answered by AI
Does this medical experiment still accept new participants?
"The records on clinicaltrials.gov reveal that, as of this moment, no further participants are being sought for the original trial which was first posted in October 2020 and last modified in March 2023. Conversely, there are 132 other medical trials currently recruiting patients."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger