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Ranibizumab vs Dexamethasone Implant in Vitrectomized Eyes With Diabetic Macular Edema

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: NCT04089605
Recruitment Status : Completed
First Posted : September 13, 2019
Last Update Posted : September 13, 2019
Sponsor:
Information provided by (Responsible Party):
Jia-Kang Wang, Far Eastern Memorial Hospital

Brief Summary:
Vitrectomy is required for removal of vitreous hemorrhage or retinal traction tissue in some patients with proliferative diabetic retinopathy. Post-vitrectomy macular edema may occur in these diabetic patients. Intravitreal injections of anti-VEGF agents or corticosteroid are required for treating diabetic macular edema (DME) in vitrectomized eyes. Intraocular levels of various cytokines may alter in the diabetic eyes following vitrectomy. Pharmacokinetics may be different between various intraocular agents in vitrectomized eyes. Herein our study will prospectively randomize to compare the clinical behavior between intravitreal ranibizumab (IVR) and intravitreal dexamethasone implant (IDI) in vitrectomized patients with DME. To our knowledge, it is the first study involving such subject.

Condition or disease Intervention/treatment Phase
Diabetic Macular Edema Drug: dexamethasone implant Drug: Ranibizumab Phase 4

Detailed Description:

Vitrectomy is required for removal of vitreous hemorrhage or retinal traction tissue in some patients with proliferative diabetic retinopathy. Post-vitrectomy macular edema may occur in these diabetic patients. Intravitreal injections of anti-VEGF agents or corticosteroid are required for treating diabetic macular edema (DME) in vitrectomized eyes. Intraocular levels of various cytokines may alter in the diabetic eyes following vitrectomy. Pharmacokinetics may be different between various intraocular agents in vitrectomized eyes. Herein our study will prospectively randomize to compare the clinical behavior between intravitreal ranibizumab (IVR) and intravitreal dexamethasone implant (IDI) in vitrectomized patients with DME. To our knowledge, it is the first study involving such subject.

Pseudophakic vitrectomized eyes with treatment-naïve center-involved DME will be enrolled with one eye in each patient. They are randomized into one group receiving IDI every 3 to 4 months, and the other group undergoing IVR using 3 monthly plus treat-and-extend injections all with monthly follow-up for 6 months. Switch of intravitreal drugs or deferred macular laser is not allowed. Primary outcome measures include change in central foveal thickness (CFT) in 1 mm by spectral-domain optic coherence tomography, and best corrected visual acuity (BCVA) at Month 6. Primary outcome measures include change in CFT and BCVA at Month 6. Injection number, BCVA, CFT, post-injection complications, and IOP are recorded and compared with Wilcoxon signed rank test within the group and Wilcoxon rank sum test between groups. Fisher's exact test is used for categorical comparison between groups. P value less than 0.05 is considered significant.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Ranibizumab and Dexamethasone Implant in Vitrectomized Eyes With Diabetic Macular Edema
Actual Study Start Date : June 1, 2017
Actual Primary Completion Date : November 1, 2018
Actual Study Completion Date : April 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Arm Intervention/treatment
Experimental: intravitreal dexamethasone implant
The eyes undergo dexamethasone intravitreal implant 0.7 mg injections at baseline and every 3 or 4 months thereafter. Dexamethasone implants are re-injected in minimal 3-month interval if macular edema persisted or recurred with CFT more than 350 μm or manifestation of apparent submacular fluid and/or intramacular cysts. If DME subside with CFT less than 350 μm without accompanying fluid and cysts, repeated injection is mandatory in maximal 4-month interval.
Drug: dexamethasone implant
intravitreal dexamethasone implant injections in vitrectomized patients with DME
Other Name: Dexamethasone implants (Ozurdex®, Allergan Inc., Irvine, CA, USA)

Active Comparator: intravitreal ranibizumab
As for intravitreal ranibizumab 0.5 mg (IVR), we use OCT-guided treat-and-extend protocol for DME treatment after modifying the settings of TREX-DME study.4 The regimen include 3 monthly loading doses then extending the treatment injection interval one month more if CFT less than 350 μm without obvious submacular fluid and intramacular cysts. The injection interval shorten one month if CFT more than 350 μm or presence of obvious fluid and/or cysts. The patients are intentionally injected at most every 3 months even DME not existing.
Drug: Ranibizumab
intravitreal ranibizumab injections in vitrectomized patients with DME
Other Name: (Lucentis®, Ranibizumab (Novartis Pharma AG, Basel, Switzerland, and Genentech Inc., South San Francisco, CA, USA)




Primary Outcome Measures :
  1. BCVA at Month 6 [ Time Frame: Month 6 ]
    best-corrected visual acuity (BCVA) at the end of intervention

  2. CFT at Month 6 [ Time Frame: Month 6 ]
    central foveal thickness (CFT) at the end of intervention



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:

  • Age more than 18 years
  • Glycosylated hemoglobin (HbA1c) less than 10.0%
  • Best-corrected visual acuity (BCVA) between 20/400 to 20/40
  • Central foveal thickness (CFT) more than 300 μm in the 1-mm central macular subfield on spectral domain optical coherence tomography (SD-OCT, CIRRUS™ HD-OCT 5000, Carl Zeiss Meditec Inc., Dublin, CA, USA) using 6 radial line scans through the fovea
  • Macular leakage on fundus fluorescein angiography (HRA2, Heidelberg Engineering GmbH, Germany)
  • The DME pattern can include submacular fluid, cystoid change, and diffuse macular thickening
  • All have proliferative diabetic retinopathy treated by panretinal photocoagulation receiving prior vitrectomy without silicone oil or gas inside the vitreous cavity
  • Prior intraocular surgery performed as least 3 months ago

Exclusion Criteria:

  • Pregnant or nursing women
  • The patients with the history of thromboembolic events or major surgery within the previous 3 months
  • Presence of anterior chamber intraocular lens or subluxated/dislocated posterior chamber intraocular lens
  • Presence of uncontrolled hypertension
  • Known coagulation abnormalities or current use of anticoagulative medication other than aspirin
  • Prior macular photocoagulation or photodynamic therapy
  • Presence of active infectious disease or intraocular inflammation
  • Intraocular pressure more than 20 mmHg or glaucoma history
  • Presence of iris neovascularization/vitreous hemorrhage.
  • The DME pattern with accompanying macular traction by epiretinal membrane or posterior hyaloid

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): NCT04089605


Locations
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Taiwan
Far Eastern Memorial Hospital
New Taipei, Taiwan, 105
Sponsors and Collaborators
Far Eastern Memorial Hospital
Investigators
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Study Chair: Shu-Wen Chang, Ph. D. Far Eastern Memorial Hospital
Publications of Results:
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Responsible Party: Jia-Kang Wang, Chief of the Vitreoretinal Section of Ophthalmology Department, Far Eastern Memorial Hospital
ClinicalTrials.gov Identifier: NCT04089605    
Other Study ID Numbers: 105136-E
First Posted: September 13, 2019    Key Record Dates
Last Update Posted: September 13, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Jia-Kang Wang, Far Eastern Memorial Hospital:
dexamethasone implant
vitrectomized
diabetic macular edema
ranibizumab
Additional relevant MeSH terms:
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Macular Edema
Edema
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Dexamethasone
Dexamethasone acetate
Ranibizumab
BB 1101
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
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors