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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02684084
Recruitment Status : Terminated (Study revised significantly. New trial to be launched.)
First Posted : February 17, 2016
Last Update Posted : August 20, 2018
Sponsor:
Collaborator:
Allergan
Information provided by (Responsible Party):
Pradeepa Yoganathan, North Toronto Eye Care Laser and Eye Specialists

Brief 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.

Condition or disease Intervention/treatment Phase
Diabetic Macular Edema Drug: Ozurdex Drug: Lucentis Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Combination OZURDEX® & LUCENTIS® vs. OZURDEX® Monotherapy in Incomplete-Responders With Diabetic Macular Edema: The COLLIDE Trial
Study Start Date : November 2015
Actual Primary Completion Date : November 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Arm Intervention/treatment
Active Comparator: Combination group (RBZ+DEX)
30 eyes will receive an intravitreal Lucentis (0.5 mg) injection followed by Ozurdex implant (0.7 mg) injection within 0 to 8 days.
Drug: Ozurdex
OZURDEX® (DEX implant; Allergan Inc. Irvine, CA, USA) is a sustained-release biodegradable implant approved for treatment of Macular Edema secondary to central retinal vein occlusion as well as noninfectious uveitis affecting the posterior segment
Other Name: DEX implant, dexamethasone

Drug: Lucentis
LUCENTIS® (0.5 mg ranibizumab or RBZ, an anti-neovascular VEGF-A inhibitor, Novartis Pharmaceuticals Canada Inc.) was the first approved medical treatment for DME
Other Name: Ranibizumab

Active Comparator: Monotherapy group (DEX only)
30 eyes will receive Ozurdex implant (0.7 mg) injection only
Drug: Ozurdex
OZURDEX® (DEX implant; Allergan Inc. Irvine, CA, USA) is a sustained-release biodegradable implant approved for treatment of Macular Edema secondary to central retinal vein occlusion as well as noninfectious uveitis affecting the posterior segment
Other Name: DEX implant, dexamethasone




Primary Outcome Measures :
  1. Comparison of mean change from baseline ETDRS BCVA letters [ Time Frame: From randomization (0) to 24+/- 1 weeks ]
    Carried out using Area Under the Curve (AUC) analysis


Secondary Outcome Measures :
  1. Mean change in Central Subfield Thickness (CST) [ Time Frame: From randomization (0) to 24+/- 1 weeks ]
    Carried out using AUC analysis

  2. Number of re-injections [ Time Frame: From randomization (0) to 24+/- 1 weeks ]
    injections needed in 24 +/- 1 weeks

  3. Re-injection interval [ Time Frame: From randomization (0) to 24+/- 1 weeks ]
    time between injections in 24 +/- 1 weeks

  4. Proportion of eyes with 15- and 10-ETDRS letters gained/lost [ Time Frame: From randomization (0) to 24+/- 1 weeks ]
    percentage of eyes enrolled with 2 and 3 lines gained

  5. Proportion of study eyes with Proliferative Diabetic Retinopathy (PDR) at study completion [ Time Frame: From randomization (0) to 24+/- 1 weeks ]
    percentage of eyes enrolled with neovascularization at 6 months



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02684084


Locations
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Canada, Ontario
Toronto Retina Institue
Toronto, Ontario, Canada, M3C 0G9
North Toronto Eye Care Laser and Eye Specialists
Toronto, Ontario, Canada, M3N 2V6
Sponsors and Collaborators
North Toronto Eye Care Laser and Eye Specialists
Allergan
Investigators
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Principal Investigator: Pradeepa Yoganathan, MD, MSc
Publications:

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Responsible Party: Pradeepa Yoganathan, Principal Investigator, North Toronto Eye Care Laser and Eye Specialists
ClinicalTrials.gov Identifier: NCT02684084    
Other Study ID Numbers: IIT-CAN-EYE-0399
First Posted: February 17, 2016    Key Record Dates
Last Update Posted: August 20, 2018
Last Verified: August 2018
Keywords provided by Pradeepa Yoganathan, North Toronto Eye Care Laser and Eye Specialists:
Diabetic Macular Edema
Ozurdex
Lucentis
Additional relevant MeSH terms:
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Macular Edema
Edema
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Dexamethasone
Ranibizumab
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors