Therapeutic Contact Lens Drug Delivery System (TCL-DDS) in Patients With Recurrent Cystoid Macular Edema

• Status: Recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

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. 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.

2. Comfort and tolerability: to establish the subject tolerability and comfort of the TCL-DDS.

3. Feasibility: To establish- that a topical dexamethasone delivery system is a feasible treatment for recurrent cystoid macular edema.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts Eye and Ear Infirmary
• Treatments: BB 1101; Dexamethasone; Dexamethasone acetate

Criteria

Inclusion Criteria

1. Adults between the ages of 18 and 85

2. Willingness to participate in the study and provide informed consent

3. Corneal thickness between 480 and 620 µm in the study eye by anterior segment OCT.

4. 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.

5. BCVA between 19 letters (approximately 20/400 Snellen equivalent) and 68 letters (approximately 20/40 Snellen equivalent) in the study eye using the ETDRS method at screening.

6. 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

7. 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

8. Recurrence of cystoid macular edema in the study eye

9. Patients who have received intravitreal triamcinolone acetonide in the study eye must satisfy the following:

a. The most recent dose was at least 8 weeks prior to screening

10. No treatment-related adverse event was seen that, in the opinion of the investigator, has the potential to worsen or reoccur with study treatment.

11. 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)

12. BCVA of <19 letters (worse than 20/400 Snellen equivalent) in the non-study eye using the ETDRS method at screening visit

13. Aphakia or pseudophakia in the study eye

Exclusion Criteria

Systemic

1. Renal failure requiring hemodialysis or peritoneal dialysis within 6 months prior to screening

2. 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

3. Use of oral carbonic anhydrase inhibitor within 1 month of screening

4. Use of immunosuppressants, immunomodulators, antimetabolites and/or alkylating agents within 6 months prior to screening or anticipated use at any time during the study

5. Known allergy or hypersensitivity to the study medication or its components

6. Medical history positive for HIV

7. 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

8. Female patients who are pregnant, nursing, or planning a pregnancy, or who are of childbearing potential and not using a reliable means of contraception

9. Participation in an investigational drug or device study within the 30 days prior to screening

10. 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

1. Contraindication to pupil dilation in either eye

2. Any active ocular infection (i.e., bacterial, viral, parasitic, or fungal) in either eye at screening

3. History of central serous chorioretinopathy in either eye

4. History of IOP elevation in response to steroid treatment in either eye that resulted in any of the following:

1. ≥ 10 mm Hg increase in IOP from screening visit with an absolute IOP ≥ 25 mm Hg

2. required therapy with 3 or more anti-glaucoma medications

5. History of failure to respond positively to a periocular or intravitreal steroid injection in either eye.

Study Eye

1. Pinhole score of > 68 (better than Snellen Equivalent 20/40) in the study eye

2. 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)

3. 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)

4. Use of non-steroidal anti-inflammatory eye drops (NSAID), steroid drops, or carbonic anhydrase inhibitor drops within 1 month prior to screening

5. Presence of any other condition in the study eye severe enough to prevent improvement in visual acuity despite reduction in macular edema

6. History of glaucoma or optic nerve head change consistent with glaucoma damage, and/or glaucomatous visual field loss in the study eye

7. Ocular hypertension in the study eye at screening visit determined by any of the following:

a. IOP > 23 mm Hg if taking no anti-glaucoma medications

8. Active optic disc or retinal neovascularization in the study eye at screening

9. Active or history of choroidal neovascularization in the study eye

10. Presence of rubeosis iridis in the study eye at screening

11. History of herpetic infection in the study eye or adnexa

12. 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)

13. Intraocular surgery, including cataract surgery, and/or laser of any type in the study eye within 30 days prior to screening

14. History of pars plana vitrectomy in the study eye

15. History of use of intravitreal bevacizumab, ranibizumab or pegaptanib in the study eye within 3 months prior to screening

16. Treated with intravitreal injections of dexamethasone implant 0.7 mg (Ozurdex®) within 6 months of screening

17. 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

18. Except at the time of surgery, any periocular depot of steroids to the study eye within 3 months prior to screening

19. 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

20. Presence of guttae or descemet's folds in the study eye.

21. Corneal pannus with presence of blood vessels 2 mm into the cornea.

Non-study Eye

1. Pinhole score < 19 letters (at least 20/400 Snellen equivalent) in the non-study eye at screening visit