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Corticosteroid
Therapeutic Contact Lens for Macular Edema (ContactLens Trial)
Phase 1 & 2
Recruiting
Research Sponsored by Massachusetts Eye and Ear Infirmary
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosis of cystoid macular edema in the study eye defined as macular edema involving the center of the macula (fovea) with one or more of the following OCT characteristics: retinal cysts, retinal thickening, and/ or subretinal fluid
Patients who have received intravitreal triamcinolone acetonide in the study eye must satisfy the following:
Must not have
Media opacity in the study eye at screening that precludes clinical and photographic evaluation (including but not limited to preretinal or vitreous hemorrhage, lens opacity)
History of pars plana vitrectomy in the study eye within 3 months prior to screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 days
Awards & highlights
No Placebo-Only Group
All Individual Drugs Already Approved
Approved for 60 Other Conditions
Summary
This trial is to study the safety, tolerability, and feasibility of using a dexamethasone-eluting contact lens to treat cystoid macular edema.
Who is the study for?
Adults aged 18-85 with recurrent cystoid macular edema who've previously responded to steroid treatments can join. They must have specific levels of visual acuity and retinal thickness, and not be at the intravitreal injection phase or beyond. Pregnant women or those on certain medications like systemic steroids are excluded.
What is being tested?
The trial is testing a dexamethasone-eluting contact lens for safety, tolerability, comfort, and feasibility in treating recurrent cystoid macular edema. Participants will wear this therapeutic lens to see if it effectively delivers medication directly to the eye.
What are the potential side effects?
Potential side effects may include discomfort from wearing contact lenses, possible ocular adverse events such as increased eye pressure or infection risk identified by regular eye examinations throughout the study period.
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 swelling in the center of my retina.
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I have received a specific eye injection in my study eye.
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My eye condition, cystoid macular edema, has come back.
Select...
I am between 18 and 85 years old.
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I have had cataract surgery on my study eye.
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My eye condition improved with steroid treatment in the past year.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My study eye is clear and can be evaluated.
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I had a specific eye surgery (pars plana vitrectomy) in the last 3 months.
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I haven't used any immune system affecting drugs in the last 6 months.
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I am HIV positive.
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I have blood vessels growing into my cornea.
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My eye has active abnormal blood vessel growth.
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I cannot wear a specific type of contact lens comfortably for an hour.
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I have a condition in my eye that could stop my vision from getting better even if the swelling reduces.
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My eye pressure is over 25 mm Hg and I'm not on glaucoma meds.
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My eye has abnormal blood vessel growth on the iris.
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I cannot have my pupils dilated due to a medical condition.
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I have advanced glaucoma or significant vision loss due to glaucoma in one eye.
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I do not have any eye infections.
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I did not improve after a steroid injection in my eye.
Select...
I have only used certain medications in my eye, and not in high doses, in the last 3 months.
Select...
I have not used any form of steroids in the last month and do not plan to use them during the study.
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I have needed dialysis for kidney failure in the last 6 months.
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My eye pressure increased due to steroid treatment.
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I have had central serous chorioretinopathy in the past.
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I am not pregnant, nursing, planning to become pregnant, or if I can bear children, I am using reliable contraception.
Select...
I have not had eye surgery or laser treatment in the study eye within the last 30 days.
Select...
I haven't used NSAID or steroid eye drops in the last month.
Select...
My eye pressure increased by 10 mm Hg or more and is now 25 mm Hg or higher, requiring 3 or more glaucoma medications.
Select...
I have or had abnormal blood vessel growth in my eye.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 28 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Occurrence of Contact Lens Related Ocular Infection
Occurrence of Corneal epithelial Defect
Occurrence of ocular hypertension greater than 28
Secondary study objectives
Changes is Visual Acuity
OCT Macular Thickness Change
Percentage of subject that achieve OCT Macular Thickness Decrease of 50 μm
+2 moreOther study objectives
Changes in Modified Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8)
Side effects data
From 2013 Phase 4 trial • 122 Patients • NCT014749152%
Deep Vein Thrombosis
2%
Cerebrospinal fluid leak
2%
Fever
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ondansetron
Aprepitant
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 60 Other Conditions
This treatment demonstrated efficacy for 60 other conditions.
Trial Design
1Treatment groups
Experimental Treatment
Group I: DexamethasoneExperimental Treatment1 Intervention
Therapeutic Contact Lens Drug Delivery System (TCL-DDS) of Dexamethasone, up to 300 μg per day with a total release of 1,100 μg over 7 days
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexamethasone
FDA approved
Find a Location
Who is running the clinical trial?
Massachusetts Eye and Ear InfirmaryLead Sponsor
109 Previous Clinical Trials
13,148 Total Patients Enrolled
1 Trials studying Macular Edema
150 Patients Enrolled for Macular Edema
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My study eye is clear and can be evaluated.I have been diagnosed with a specific type of swelling in the center of my retina.I had a specific eye surgery (pars plana vitrectomy) in the last 3 months.I haven't used any immune system affecting drugs in the last 6 months.I am HIV positive.I have blood vessels growing into my cornea.My eye has active abnormal blood vessel growth.I cannot wear a specific type of contact lens comfortably for an hour.I have not taken carbonic anhydrase inhibitors in the last month.I have a condition in my eye that could stop my vision from getting better even if the swelling reduces.My eye pressure is over 25 mm Hg and I'm not on glaucoma meds.My eye has abnormal blood vessel growth on the iris.I cannot have my pupils dilated due to a medical condition.I have advanced glaucoma or significant vision loss due to glaucoma in one eye.I have received a specific eye injection in my study eye.My eye condition, cystoid macular edema, has come back.My eye condition does not prevent me from wearing a contact lens.I do not have any eye infections.I did not improve after a steroid injection in my eye.I have only used certain medications in my eye, and not in high doses, in the last 3 months.I have not used any form of steroids in the last month and do not plan to use them during the study.I am between 18 and 85 years old.I have received Ozurdex® eye injections in the last 6 months.I have had cataract surgery on my study eye.I am in the early stage of my eye treatment, using only anti-inflammatory drops.I have needed dialysis for kidney failure in the last 6 months.My eye pressure increased due to steroid treatment.I have had central serous chorioretinopathy in the past.I am not pregnant, nursing, planning to become pregnant, or if I can bear children, I am using reliable contraception.I have not had eye surgery or laser treatment in the study eye within the last 30 days.My eye pressure is high as determined during my screening visit.I haven't received eye steroid injections near my surgery date.Eye drops no longer work for me; only steroid injections help.I am a woman who can have children and have a negative pregnancy test.I haven't used NSAID or steroid eye drops in the last month.My eye pressure increased by 10 mm Hg or more and is now 25 mm Hg or higher, requiring 3 or more glaucoma medications.My eye condition improved with steroid treatment in the past year.I have or had abnormal blood vessel growth in my eye.I haven't had eye injections with bevacizumab, ranibizumab, or pegaptanib in the last 3 months.I am willing to join the study and can give my consent.
Research Study Groups:
This trial has the following groups:- Group 1: Dexamethasone
Awards:
This trial has 3 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 60 Other Conditions - This treatment demonstrated efficacy for 60 other conditions.
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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