Cystoid Macular EdemaPhase 1/2ContactLensNCT04225611
Therapeutic Contact Lens Drug Delivery System (TCL-DDS) in Patients With Recurrent Cystoid Macular Edema
A Phase 1/2 study testing Dexamethasone in people with Cystoid Macular Edema, run by Massachusetts Eye and Ear Infirmary at 1 site in United States.
Trial summary
The main aim of the pilot study is to determine preliminary estimates of the safety, tolerability, and comfort of a dexamethasone-eluting therapeutic contact lens drug delivery system (TCL-DDS) for the treatment of recurrent cystoid macular edema. Secondarily, feasibility of the TCL-DDS system will be investigated. 1. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Cystoid Macular Edema
- What is being tested?
- Dexamethasone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Mar 2021to 31 Dec 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults between the ages of 18 and 85 Willingness to participate in the study and provide informed consent For Phase A, patients who only respond to anti-inflammatory drops (not at the intravitreal steroid injection phase of care yet).
- For Phase B, patients who only respond to steroid intravitreal injections (anti-inflammatory drops are no longer therapeutically working for these patients).
- Corneal thickness between 480 and 620 µm in the study eye by anterior segment OCT.
- 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.
- Visual acuity between 20/400 and 20/25 in the study eye, measured by pinhole VA.
- Retinal thickness above 300 µm as measured by OCT in the 1mm central macular subfield of the study eye at screening as determined by the investigator History of positive response to topical or intraocular steroid treatment defined as 50 µm thinning in response to steroid treatment in the study eye within 1 year Recurrence of cystoid macular edema in the study eye
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- Patients who have received intravitreal triamcinolone acetonide in the study eye must satisfy the following:
- The most recent dose was at least 8 weeks prior to screening No treatment-related adverse event was seen that, in the opinion of the investigator, has the potential to worsen or reoccur with study treatment.
- Female patients of childbearing potential must have a negative urine pregnancy test at the enrollment (day 0) visit (repeat at day 0 if greater than 14 days past Screening Visit) Aphakia or pseudophakia in the study eye
Who cannot join
- Systemic Renal failure requiring hemodialysis or peritoneal dialysis within 6 months prior to screening Use of systemic steroids (e.g., oral, intravenous, intra-articular, epidural, intrabursal, inhaled, or intranasal) within 1 month prior to the qualification/baseline visit or anticipated use at any time during the study Use of oral carbonic anhydrase inhibitor within 1 month of screening Use of immunosuppressants, immunomodulators, antimetabolites and/or alkylating agents within 6 months prior to screening or anticipated use at any time during the study Known allergy or hypersensitivity to the study medication or its components Medical history positive for HIV Any condition (including inability to read visual acuity charts or language barrier) which precludes patient's ability to comply with study requirements including completion of the study Female patients who are pregnant, nursing, or planning a pregnancy, or who are of childbearing potential and not using a reliable means of contraception Participation in an investigational drug or device study within the 30 days prior to screening Patient has a condition or is in a situation which, in the Investigator's opinion, may put the patient at significant risk, may confound the study results, or may interfere significantly with the patient's participation in the study
- Both Eyes Contraindication to pupil dilation in either eye Any active ocular infection (i.e., bacterial, viral, parasitic, or fungal) in either eye at screening History of central serous chorioretinopathy in either eye
- History of IOP elevation in response to steroid treatment in either eye that resulted in any of the following:
- ≥ 10 mm Hg increase in IOP from screening visit with an absolute IOP ≥ 25 mm Hg required therapy with 3 or more anti-glaucoma medications History of failure to respond positively to a periocular or intravitreal steroid injection in either eye.
- Study Eye [This exclusion has been removed.] Any ocular condition in the study eye that in the opinion of the investigator would prevent a 15-letter improvement in visual acuity (e.g., fibrosis, retinal atrophy, severe macular ischemia, extensive macular laser scarring or atrophy) Any ocular condition in the study eye that in the opinion of the investigator would prevent the eye from wearing a contact lens (e.g., ectropion, lid abnormality, or symblepharon) Use of non-steroidal anti-inflammatory eye drops (NSAID) or steroid drops within 1 month prior to screening Presence of any other condition in the study eye severe enough to prevent improvement in visual acuity despite reduction in macular edema History of advanced glaucoma / optic nerve head change consistent with glaucoma damage, and/or advanced glaucomatous visual field loss in the study eye
- Ocular hypertension in the study eye at screening visit determined by the following:
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- IOP > 25 mm Hg if taking no anti-glaucoma medications Active optic disc or retinal neovascularization in the study eye at screening Active or history of choroidal neovascularization in the study eye Presence of rubeosis iridis in the study eye at screening History of herpetic infection in the study eye or adnexa 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) Intraocular surgery, including cataract surgery, and/or laser of any type in the study eye within 30 days prior to screening History of pars plana vitrectomy in the study eye within 3 months prior to screening History of use of intravitreal bevacizumab, ranibizumab or pegaptanib in the study eye within 3 months prior to screening Treated with intravitreal injections of dexamethasone implant 0.7 mg (Ozurdex®) within 6 months of screening History of use of any intravitreal agent in the study eye other than corticosteroid, bevacizumab, ranibizumab, or pegaptanib, or intravitreal doses of triamcinolone acetonide > 4mg, bevacizumab > 1.25 mg, ranibizumab > 0.5 mg, or pegaptanib > 0.3 mg within 3 months prior to screening.
- Except at the time of surgery, any periocular depot of steroids to the study eye within 3 months prior to screening Inability to comfortably wear a commercial contact lens (Kontur) that has the same dimensions as the TCL-DDS during a 1 hour run-in period Presence of guttae or descemet's folds in the study eye. Corneal neovascularization with presence of blood vessels 2 mm into the cornea.
- Non-study Eye Pinhole score <19 letters in the non-study eye at screening visit.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
MEEI
Boston, Massachusetts, 02114
Grayson Hanlon
About this study
Official title: Randomized, Prospective, Vehicle-Controlled, Phase I/II Clinical Trial to Evaluate the Safety and Feasibility of a Therapeutic Contact Lens Drug Delivery System (TCL-DDS) in Patients With Recurrent Cystoid Macular Edema
The main aim of the pilot study is to determine preliminary estimates of the safety, tolerability, and comfort of a dexamethasone-eluting therapeutic contact lens drug delivery system (TCL-DDS) for the treatment of recurrent cystoid macular edema. Secondarily, feasibility of the TCL-DDS system will be investigated.
- Safety: To establish that a topical dexamethasone delivery system has an acceptable safety profile by determining the incidence and severity of ocular adverse events, as identified by eye examination through day 28 following treatment initiation.
- Comfort and tolerability: to establish the subject tolerability and comfort of the TCL-DDS.
- Feasibility: To establish- that a topical dexamethasone delivery system is a feasible treatment for recurrent cystoid macular edema.
Read the detailed description
This is a single center study to assess safety and feasibility of delivering dexamethasone through the TCL-DDS delivery system as a treatment for recurrent cystoid macular edema. The study has two phases. The study begins with phase A, which is an open label study in that will enroll up to 6 subject. The goal of this phase is to have 3 subjects complete the study. The enrollment number is 6 in order to accommodate for withdraws and/or terminations (for reasons other than adverse event to the study intervention and include loss of the lens before 7 days). Subjects will wear the TCL-DDS in one eye for one week during which time they will be closely followed with examinations at 1 hour, 6 hours, 24 hours, 3 days, and 7 days. After the TCL-DDS is removed after 7 days of wear, the subjects will be followed with weekly examinations for 3 additional weeks for evaluation of safety. If the TCL-DDS is found to be safe after review of the clinical data by monitoring board, phase B will be initiated that will study the safety and effectiveness of delivering dexamethasone through the TCL-DDS. This clinical trials submission only relates to phase A of the study design.
During Phase A, a commercial contact lens (Kontur Kontact Lens, Hercules, CA) that has the same dimensions and thickness (16.0 mm diameter and 8.6 mm base curve) as the TCL-DDS will be placed on the study eye and worn for a 1 hour run-in period. This run in period will be used to help identify subjects who can tolerate a contact lens with the same dimensions and parameters as the TCL-DDS. Those subjects that cannot wear the commercial contact lens due to problems with fitting of the lens, comfort, or other reasons will be excluded from the study. We will evaluate comfort and examine the eye for signs of ocular irritation and inflammation, which may include slit lamp findings of conjunctiva redness, the pattern of any conjunctiva redness, anterior chamber reaction, discharge, and pupillary dilation.
If the contact lens is worn comfortably without signs of ocular irritation, then the commercial lens will be removed and replaced with a TCL-DDS. The eye will be examined at 1 hour, 6 hours, 24 hours, 3 days, and 7 days. We will evaluate comfort and examine the eyes for signs of ocular irritation by slit lamp examination. In addition, we will check intraocular pressure on day 7.
The eye will be assessed again at Day 14, 21, and 28. During the examinations, the study eyes will have the intraocular pressure measured and will be evaluated by slit lamp examination for associated adverse events to determine the safety of the TCL-DDS. Phone call assessments in place of scheduled clinic visits will be completed on Day 2 and Day 4 for safety checks. Information on adverse events will be collected at each study visit, including phone visits, from screening to Day 28. The subject will then attend a final follow up evaluation visit at Day 28 that will conclude the subject's participation in the study.
After the first 3 subject s (up to 6 subjects enrolled) in Phase A complete their day 28 visit, and it is determined that the TCL-DDS is safe and well tolerated, 15 additional subjects will be enrolled into Phase B of the study.
- Conditions
- Cystoid Macular Edema
- Being tested
- Dexamethasone
- Keywords
- contact lens, drug, cystoid, macular edema
- Medical subject headings
- Macular Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
Also called (TCL-DDS)
The investigators have developed a topically-applied corticosteroid-delivery system that has the potential to treat recurrent cystoid macular edema with fewer risks to patient, and more dose control. The system is comprised of a drug-polymer film that is completely encapsulated within the periphery of a hydrogel that is commonly used to make contact lenses.
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone | Experimental | 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 Receives: Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of Contact Lens Related Ocular Infection
Number of ocular infection incidents for the duration of the study
Measured: 28 Days
Occurrence of Corneal epithelial Defect
Number of corneal epithelial defects incidents for the duration of the study
Measured: 28 Days
Occurrence of ocular hypertension greater than 28
Number of ocular hypertension incidents for the duration of the study (ocular hypertension greater than 28)
Measured: 28 Days
Secondary outcomes (5)
OCT Macular Thickness Change
Changes in ocular coherence tomography (OCT) macular thickness over the duration of the study
Measured: 28 Days
Percentage of subject that achieve OCT Macular Thickness Decrease of 50 μm
Percentage of subjects that achieve a 50 μm decrease in OCT macular thickness from baseline to study completion
Measured: 28 Days
Changes is Visual Acuity
Change in vision (letter gain with and without pinhole vision) from baseline to the end of the study.
Measured: 28 Days
Percentages of subjects with 15 letter gain
Percentage of subjects that achieve a 15 letter gain from baseline to the end of the study
Measured: 28 Days
Percentage of subjects that require rescue Medication
Percentage of subjects that require rescue medication at day 21
Measured: Day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2020
- Study start15 Mar 2021
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystoid Macular EdemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The study begins with phase A, which is an open label study in that will enroll up to 6 subjects. The goal of this phase is to have 3 subjects complete the study. The enrollment number is 6 in order to accommodate for withdraws and/or terminations (for reasons other than adverse event to the study intervention and include loss of the lens before 7 days). Subjects will wear the TCL-DDS in one eye for 3 days during which time they will be closely followed with examinations at 1 hour, 6 hours, 24 hours, 3 days, and 7 days. After the TCL-DDS is removed after 3 days of wear, the subjects will be followed with weekly examinations for 3 additional weeks for evaluation of safety.
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts Eye and Ear Infirmary
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Demetrios Vavvas, Massachusetts Eye and Ear Infirmary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04225611
- Sponsor's protocol ID
- 2019P001550
- Acronym
- ContactLens
- Status last verified
- Nov 2025
- First submitted
- 13 Nov 2019
- Last updated
- 26 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Prospective, Vehicle-Controlled, Phase I/II Clinical Trial to Evaluate the Safety and Feasibility of a Therapeutic Contact Lens Drug Delivery System (TCL-DDS) in Patients With Recurrent Cystoid Macular Edema
- ClinicalTrials.gov ID
- NCT04225611
- Acronym / sponsor ID
- ContactLens / 2019P001550
- Conditions
- Cystoid Macular Edema
- Keywords
- contact lens, drug, cystoid, macular edema
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- Massachusetts Eye and Ear InfirmaryUniversity, hospital or other
- Study start
- 15 Mar 2021 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 13 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main aim of the pilot study is to determine preliminary estimates of the safety, tolerability, and comfort of a dexamethasone-eluting therapeutic contact lens drug delivery system (TCL-DDS) for the treatment of recurrent cystoid macular edema. Secondarily, feasibility of the TCL-DDS system will be investigated.
- Safety: To establish that a topical dexamethasone delivery system has an acceptable safety profile by determining the incidence and severity of ocular adverse events, as identified by eye examination through day 28 following treatment initiation.
- Comfort and tolerability: to establish the subject tolerability and comfort of the TCL-DDS.
- Feasibility: To establish- that a topical dexamethasone delivery system is a feasible treatment for recurrent cystoid macular edema.
Detailed description
This is a single center study to assess safety and feasibility of delivering dexamethasone through the TCL-DDS delivery system as a treatment for recurrent cystoid macular edema. The study has two phases. The study begins with phase A, which is an open label study in that will enroll up to 6 subject. The goal of this phase is to have 3 subjects complete the study. The enrollment number is 6 in order to accommodate for withdraws and/or terminations (for reasons other than adverse event to the study intervention and include loss of the lens before 7 days). Subjects will wear the TCL-DDS in one eye for one week during which time they will be closely followed with examinations at 1 hour, 6 hours, 24 hours, 3 days, and 7 days. After the TCL-DDS is removed after 7 days of wear, the subjects will be followed with weekly examinations for 3 additional weeks for evaluation of safety. If the TCL-DDS is found to be safe after review of the clinical data by monitoring board, phase B will be initiated that will study the safety and effectiveness of delivering dexamethasone through the TCL-DDS. This clinical trials submission only relates to phase A of the study design.
During Phase A, a commercial contact lens (Kontur Kontact Lens, Hercules, CA) that has the same dimensions and thickness (16.0 mm diameter and 8.6 mm base curve) as the TCL-DDS will be placed on the study eye and worn for a 1 hour run-in period. This run in period will be used to help identify subjects who can tolerate a contact lens with the same dimensions and parameters as the TCL-DDS. Those subjects that cannot wear the commercial contact lens due to problems with fitting of the lens, comfort, or other reasons will be excluded from the study. We will evaluate comfort and examine the eye for signs of ocular irritation and inflammation, which may include slit lamp findings of conjunctiva redness, the pattern of any conjunctiva redness, anterior chamber reaction, discharge, and pupillary dilation.
If the contact lens is worn comfortably without signs of ocular irritation, then the commercial lens will be removed and replaced with a TCL-DDS. The eye will be examined at 1 hour, 6 hours, 24 hours, 3 days, and 7 days. We will evaluate comfort and examine the eyes for signs of ocular irritation by slit lamp examination. In addition, we will check intraocular pressure on day 7.
The eye will be assessed again at Day 14, 21, and 28. During the examinations, the study eyes will have the intraocular pressure measured and will be evaluated by slit lamp examination for associated adverse events to determine the safety of the TCL-DDS. Phone call assessments in place of scheduled clinic visits will be completed on Day 2 and Day 4 for safety checks. Information on adverse events will be collected at each study visit, including phone visits, from screening to Day 28. The subject will then attend a final follow up evaluation visit at Day 28 that will conclude the subject's participation in the study.
After the first 3 subject s (up to 6 subjects enrolled) in Phase A complete their day 28 visit, and it is determined that the TCL-DDS is safe and well tolerated, 15 additional subjects will be enrolled into Phase B of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The study begins with phase A, which is an open label study in that will enroll up to 6 subjects. The goal of this phase is to have 3 subjects complete the study. The enrollment number is 6 in order to accommodate for withdraws and/or terminations (for reasons other than adverse event to the study intervention and include loss of the lens before 7 days). Subjects will wear the TCL-DDS in one eye for 3 days during which time they will be closely followed with examinations at 1 hour, 6 hours, 24 hours, 3 days, and 7 days. After the TCL-DDS is removed after 3 days of wear, the subjects will be followed with weekly examinations for 3 additional weeks for evaluation of safety.
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone | Experimental | Drug: DexamethasoneTherapeutic 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 |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Adults between the ages of 18 and 85 Willingness to participate in the study and provide informed consent For Phase A, patients who only respond to anti-inflammatory drops (not at the intravitreal steroid injection phase of care yet).
- For Phase B, patients who only respond to steroid intravitreal injections (anti-inflammatory drops are no longer therapeutically working for these patients).
- Corneal thickness between 480 and 620 µm in the study eye by anterior segment OCT.
- 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.
- Visual acuity between 20/400 and 20/25 in the study eye, measured by pinhole VA.
Key exclusion criteria (9 listed)
- Systemic Renal failure requiring hemodialysis or peritoneal dialysis within 6 months prior to screening Use of systemic steroids (e.g., oral, intravenous, intra-articular, epidural, intrabursal, inhaled, or intranasal) within 1 month prior to the qualification/baseline visit or anticipated use at any time during the study Use of oral carbonic anhydrase inhibitor within 1 month of screening Use of immunosuppressants, immunomodulators, antimetabolites and/or alkylating agents within 6 months prior to screening or anticipated use at any time during the study Known allergy or hypersensitivity to the study medication or its components Medical history positive for HIV Any condition (including inability to read visual acuity charts or language barrier) which precludes patient's ability to comply with study requirements including completion of the study Female patients who are pregnant, nursing, or planning a pregnancy, or who are of childbearing potential and not using a reliable means of contraception Participation in an investigational drug or device study within the 30 days prior to screening Patient has a condition or is in a situation which, in the Investigator's opinion, may put the patient at significant risk, may confound the study results, or may interfere significantly with the patient's participation in the study
- Both Eyes Contraindication to pupil dilation in either eye Any active ocular infection (i.e., bacterial, viral, parasitic, or fungal) in either eye at screening History of central serous chorioretinopathy in either eye
- History of IOP elevation in response to steroid treatment in either eye that resulted in any of the following:
- ≥ 10 mm Hg increase in IOP from screening visit with an absolute IOP ≥ 25 mm Hg required therapy with 3 or more anti-glaucoma medications History of failure to respond positively to a periocular or intravitreal steroid injection in either eye.
- Study Eye [This exclusion has been removed.] Any ocular condition in the study eye that in the opinion of the investigator would prevent a 15-letter improvement in visual acuity (e.g., fibrosis, retinal atrophy, severe macular ischemia, extensive macular laser scarring or atrophy) Any ocular condition in the study eye that in the opinion of the investigator would prevent the eye from wearing a contact lens (e.g., ectropion, lid abnormality, or symblepharon) Use of non-steroidal anti-inflammatory eye drops (NSAID) or steroid drops within 1 month prior to screening Presence of any other condition in the study eye severe enough to prevent improvement in visual acuity despite reduction in macular edema History of advanced glaucoma / optic nerve head change consistent with glaucoma damage, and/or advanced glaucomatous visual field loss in the study eye
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexamethasoneAlso: (TCL-DDS)The investigators have developed a topically-applied corticosteroid-delivery system that has the potential to treat recurrent cystoid macular edema with fewer risks to patient, and more dose control. The system is comprised of a drug-polymer film that is completely encapsulated within the periphery of a hydrogel that is commonly used to make contact lenses. | Drug | Dexamethasone |
Primary outcome
Occurrence of Contact Lens Related Ocular Infection
Time frame: 28 Days
Number of ocular infection incidents for the duration of the study
Occurrence of Corneal epithelial Defect
Time frame: 28 Days
Number of corneal epithelial defects incidents for the duration of the study
Occurrence of ocular hypertension greater than 28
Time frame: 28 Days
Number of ocular hypertension incidents for the duration of the study (ocular hypertension greater than 28)
5 secondary outcomes
OCT Macular Thickness Change
Time frame: 28 Days
Percentage of subject that achieve OCT Macular Thickness Decrease of 50 μm
Time frame: 28 Days
Changes is Visual Acuity
Time frame: 28 Days
Percentages of subjects with 15 letter gain
Time frame: 28 Days
Percentage of subjects that require rescue Medication
Time frame: Day 21
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Dexamethasone in people with Cystoid Macular Edema, run by Massachusetts Eye and Ear Infirmary at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Demetrios Vavvas, M.D., Ph.D. (617-573-4174, demetrios_vavvas@meei.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of Contact Lens Related Ocular Infection (time frame: 28 Days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2025; AzTrials last refreshed its copy on 8 Nov 2026.