Ranibizumab vs Dexamethasone Implant in Vitrectomized Eyes With Diabetic Macular Edema

NCT04089605 | Completed Phase 4

• 1 other identifier: 105136-E
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Macular Edema

Keywords

dexamethasone implant; vitrectomized; diabetic macular edema; ranibizumab

Outcome Measures

Primary Outcomes (2)

• BCVA at Month 6

  best-corrected visual acuity (BCVA) at the end of intervention

  Month 6

• CFT at Month 6

  central foveal thickness (CFT) at the end of intervention

  Month 6

Study Arms (2)

intravitreal dexamethasone implant

EXPERIMENTAL

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 ranibizumab

ACTIVE COMPARATOR

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

Interventions

dexamethasone implant DRUG

intravitreal dexamethasone implant injections in vitrectomized patients with DME

Also known as: Dexamethasone implants (Ozurdex®, Allergan Inc., Irvine, CA, USA)

intravitreal dexamethasone implant

Ranibizumab DRUG

intravitreal ranibizumab injections in vitrectomized patients with DME

Also known as: (Lucentis®, Ranibizumab (Novartis Pharma AG, Basel, Switzerland, and Genentech Inc., South San Francisco, CA, USA)

intravitreal ranibizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Far Eastern Memorial Hospital: lead

Study Sites (1)

Far Eastern Memorial Hospital

New Taipei City, 105, Taiwan

Location

Related Publications (3)

• Wang JK, Huang TL, Su PY, Chang PY. An updated review of long-term outcomes from randomized controlled trials in approved pharmaceuticals for diabetic macular edema. Eye Sci. 2015 Dec;30(4):176-83.

  PMID: 27215008 RESULT

• Sonoda S, Sakamoto T, Shirasawa M, Yamashita T, Otsuka H, Terasaki H. Correlation between reflectivity of subretinal fluid in OCT images and concentration of intravitreal VEGF in eyes with diabetic macular edema. Invest Ophthalmol Vis Sci. 2013 Aug 9;54(8):5367-74. doi: 10.1167/iovs.13-12382.

  PMID: 23860753 RESULT

• Muether PS, Droege KM, Fauser S. Vascular endothelial growth factor suppression times in patients with diabetic macular oedema treated with ranibizumab. Br J Ophthalmol. 2014 Feb;98(2):179-81. doi: 10.1136/bjophthalmol-2013-303954. Epub 2013 Nov 13.

  PMID: 24227804 RESULT

MeSH Terms

Interventions

Dexamethasone; Calcium Dobesilate; Ranibizumab

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Shu-Wen Chang, Ph. D.

  Far Eastern Memorial Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of the Vitreoretinal Section of Ophthalmology Department

Study Record Dates

• First Submitted: September 1, 2019
• First Posted: September 13, 2019
• Study Start: June 1, 2017
• Primary Completion: November 1, 2018
• Study Completion: April 30, 2019
• Last Updated: September 13, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)