Ranibizumab vs Dexamethasone Implant in Vitrectomized Eyes With Diabetic Macular Edema

September 12, 2019 updated by: Jia-Kang Wang, Far Eastern Memorial Hospital

Ranibizumab and Dexamethasone Implant in Vitrectomized Eyes With Diabetic Macular Edema

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • New Taipei, Taiwan, 105
        • Far Eastern Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • (Lucentis®, Ranibizumab (Novartis Pharma AG, Basel, Switzerland, and Genentech Inc., South San Francisco, CA, USA)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
BCVA at Month 6
Time Frame: Month 6
best-corrected visual acuity (BCVA) at the end of intervention
Month 6
CFT at Month 6
Time Frame: Month 6
central foveal thickness (CFT) at the end of intervention
Month 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Far Eastern Memorial Hospital

Investigators

  • Study Chair: Shu-Wen Chang, Ph. D., Far Eastern Memorial Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2017

Primary Completion (Actual)

November 1, 2018

Study Completion (Actual)

April 30, 2019

Study Registration Dates

First Submitted

September 1, 2019

First Submitted That Met QC Criteria

September 12, 2019

First Posted (Actual)

September 13, 2019

Study Record Updates

Last Update Posted (Actual)

September 13, 2019

Last Update Submitted That Met QC Criteria

September 12, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 105136-E

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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