Overview
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.
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.
Eligibility
Inclusion Criteria
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
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
Exclusion Criteria
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:
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.