Your session is about to expire
← Back to Search
Intravitreal ONL1204 for Retinal Detachment
Phase 2
Waitlist Available
Research Sponsored by ONL Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adult subject, ≥18 years old at the time of informed consent
SOC retinal reattachment surgery by means of a pars plana vitrectomy (with or without scleral buckle) is indicated
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 24
Awards & highlights
Study Summary
This trial will look at the safety & effectiveness of a drug to improve vision in people with a common eye condition before surgery.
Who is the study for?
Adults over 18 with macula-off retinal detachment for at least 24 hours but no more than 14 days, who can safely undergo an injection in the eye. They must have certain levels of vision in both eyes and be scheduled for surgery within a specific timeframe. Excluded are those with complex detachments, previous significant eye surgeries or conditions, uncontrolled glaucoma, ocular infections or inflammations, autoimmune diseases affecting the eyes, pregnancy, or not using effective contraception.Check my eligibility
What is being tested?
The trial is testing ONL1204 Ophthalmic Solution to see if it improves vision when used before surgery for macula-off retinal detachment compared to standard treatment (no drug). Patients will receive either a low dose (50 µg), high dose (200 µg) of ONL1204 or a sham treatment before their scheduled surgery.See study design
What are the potential side effects?
While specific side effects aren't listed here, potential risks may include typical reactions related to intravitreal injections such as eye pain or discomfort, inflammation inside the eye, bleeding complications and possible worsening of vision.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I am recommended to have surgery to fix a detached retina.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 24
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 24
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Mean area under the log contrast sensitivity function (AULCSF)
Secondary outcome measures
AULCSF
BCVA
Mean best-corrected visual acuity (BCVA) measured in logarithm of the minimum angle of resolution (logMAR)
Side effects data
From 2015 Phase 4 trial • 157 Patients • NCT020033916%
Ocular hyperaemia
5%
Eye pruritus
2%
Nasopharyngitis
2%
Dry eye
1%
Acute tonsillitis
1%
Conjunctivitis allergic
1%
Eyelids pruritus
1%
Blepharal pigmentation
1%
Pharyngitis
1%
Eye irritation
1%
Cataract
1%
Arthritis
1%
Hypersensitivity
1%
Eye pain
1%
Ocular surface disease
100%
80%
60%
40%
20%
0%
Study treatment Arm
DuoTrav
Beta-blocker
Trial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Treatment Group BExperimental Treatment1 Intervention
ONL1204 Ophthalmic Solution Dose B administered by intravitreal injection
Group II: Treatment Group AExperimental Treatment1 Intervention
ONL1204 Ophthalmic Solution Dose A administered by intravitreal injection
Group III: Treatment Group CPlacebo Group1 Intervention
Sham injection is performed by touching the eye surface with a syringe without a needle
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ONL1204 Ophthalmic Solution
2023
Completed Phase 2
~140
Find a Location
Who is running the clinical trial?
ONL TherapeuticsLead Sponsor
3 Previous Clinical Trials
67 Total Patients Enrolled
1 Trials studying Retinal Detachment
14 Patients Enrolled for Retinal Detachment
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My retina is detached due to an eye injury.My doctor thinks I can safely have an IVT injection.My eye has a complex retinal detachment.My eye condition is classified as severe or worse.My eye condition involves scar tissue pulling on the retina.My retina detachment followed an eye infection.I have an eye infection or inflammation around or in my eye.My eye pressure is not higher than 36 mmHg.I have had eye surgery for retinal detachment or other serious conditions.I have cancer in my eye.I have advanced diabetic eye disease.I am not pregnant, breastfeeding, and if capable of childbearing or with a partner who is, we use effective birth control.I am 18 years old or older.My retina detached over 24 hours ago but less than 14 days, affecting my central vision.My surgery is planned for more than 12 hours after an injection but within 10 days of my screening.I have a history of or currently have a specific condition.You have an autoimmune disease that is not well controlled with current medication and is affecting your eyes. The doctor thinks it could affect your ability to participate in the trial or the success of the surgery.I am recommended to have surgery to fix a detached retina.I have had a silicone oil tamponade for retinal detachment that won't be removed soon.Your rare disease is considered too complicated by the investigator.I don't have major eye diseases that would prevent good vision after surgery.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment Group C
- Group 2: Treatment Group B
- Group 3: Treatment Group A
Awards:
This trial has 0 awards, including: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.
Has Treatment Group A attained regulatory approval by the FDA?
"Our expert team at Power rated Treatment Group A as a 2, given it is only in Phase 2 and does not yet have any confirmatory data for therapeutic effectiveness."
Answered by AI
Are there any open slots for participation in this experiment?
"Data housed on clinicaltrials.gov indicates that participants are currently being sought for this study, which was inaugurated on May 1st 2023 and most recently updated April 10th 2023."
Answered by AI
How many sites are overseeing the execution of this research?
"Currently, this trial is taking patients from seven different clinics. These are based in Pensacola, Elmhurst and Erie as well as several other nearby locations. To minimise the travel burden of enrolment, participants should select a clinic that is closest to them."
Answered by AI
What is the size of the participant group for this research endeavor?
"Affirmative, the information housed at clinicaltrials.gov reveals that this trial is presently recruiting patients. This medical research was opened on May 1st 2023 and has been modified as recently as April 10th 2023. Seven different sites are looking for 135 participants to participate in the study."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger