Combination OZURDEX® & LUCENTIS® vs. OZURDEX® Monotherapy in Incomplete-Responders With Diabetic Macular Edema

• Status: Terminated
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a 24-week, prospective, multi-center, open-label, randomized, investigator-initiated pilot study to explore the effects of RBZ (0.5 mg) plus DEX implant (0.7 mg) PRN combination therapy (n = 30) vs. DEX implant PRN monotherapy (n = 30) in pseudophakic eyes with center-involved DME that have demonstrated prior incomplete response to 3-6 anti-VEGF treatments.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: North Toronto Eye Care Laser and Eye Specialists
• Collaborator: Allergan
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Ranibizumab

Criteria

Inclusion Criteria:

1. Type 1 or 2 diabetic patients

2. Pseudophakic (or phakic without cataract;<1+ nuclear sclerosis) lens status with intact posterior lens capsule and / or Nd:YAG laser capsulotomy that in the investigator's opinion is not likely to permit dislocation of DEX implant into the anterior chamber

3. Center-involved DME > 250 µm

4. Baseline BCVA between 20/40 - 20/320

5. Duration of DME ≤ 9 months

6. Glycosylated haemoglobin (HbA1c) levels ≤ 11%

7. Eyes with intraocular pressure (IOP) ≤ 21 and / or treatment with < 2 topical IOP-lowering medications (eyes with history of previous angle -closure or similar conditions that have been successfully treated with either laser or surgical intervention are allowed as long as the visual fields and optic nerves have been stable for > 1 year prior to study entry and the patient has been and can be safely dilated)

8. Demonstrated incomplete response to 3-6 prior intravitreal anti-VEGFs (AVASTIN®, LUCENTIS®, or EYLEA®; administered every 4 ± 2 weeks over 12-36 weeks (or 3-9 months)); incomplete response is defined herein as a treatment effect resulting in:

1. < 20% reduction in central subfield thickness (CST) by SD-OCT compared to the baseline first RBZ injection, or

2. < 5-letter increase in visual acuity compared to the baseline first RBZ injection and/or

3. the opinion of the treating ophthalmologist additional anti-VEGF monotherapy is not deemed likely to provide further therapeutic benefit

9. If both eyes qualify investigators may enrol bilaterally, with one eye receiving the RBZ plus DEX implant combination regimen and the other receiving the DEX implant monotherapy regimen

10. Written informed patient consent

Exclusion Criteria:

1. Patients with active or suspected ocular or periocular infections including most viral diseases of the cornea and conjunctiva, including active epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, mycobacterial infections, and fungal diseases.

2. Patients with known hypersensitivity to any components of RBZ or DEX implant

3. Patient has suffered from a stroke or trans-ischemic attack (TIA) in the last 6 months

4. Patients using topical anti-inflammatory medication for the duration of the study

5. Patients with ACIOL (Anterior Chamber Intraocular Lens) and rupture of the posterior lens capsule

6. Prior panretinal or macular laser treatments

7. Previous vitrectomy

8. Any ocular condition that in the opinion of the investigator would not permit improvement of visual acuity with resolution of ME (e.g., foveal atrophy, pigment abnormalities, dense subfoveal hard exudates and/or poor foveal architecture suggestive of photoreceptor loss)

9. Patients with retinal diseases, other than diabetes that can affect ME

10. HbA1c levels > 11%

11. Eyes with a history of advanced glaucoma (optic nerve head change consistent with glaucoma damage and / or glaucomatous visual field loss), uncontrolled ocular hypertension (baseline IOP > 21 mmHg despite use of ≥ 2 topical IOP-lowering medication)

12. Eyes with a history of steroid response (i.e., increase of ≥ 5 mmHg IOP following topical steroid treatment)

13. Eyes with demonstrated response to 3-6 prior monotherapy intravitreal anti-VEGF (i.e., AVASTIN®, LUCENTIS® or EYLEA® administered every 4 ± 2 weeks over 12-36 weeks (or 3-9 months)); response is defined herein as a treatment effect resulting in:

1. ≥ 20% reduction in CST by SD-OCT from baseline first anti-VEGF injection,

2. ≥ 5-letter increase in visual acuity since the baseline first anti-VEGF injection and/or,

3. the opinion of the treating ophthalmologist additional anti-VEGF monotherapy is deemed likely to provide further therapeutic benefit

14. Female patients who are pregnant, breast feeding, or are unable to attend the scheduled follow-up study visits

15. Patients who are unable to attend scheduled follow-up visits throughout the 24-week study

16. Use of systemic steroid, anti-VEGF or pro-VEGF treatment within 4 months prior to enrolment or anticipated use during the study (these drugs are prohibited from use during the study)