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Diabetic Macular EdemaPhase 4NCT04089605

Ranibizumab vs Dexamethasone Implant in Vitrectomized Eyes With Diabetic Macular Edema

A Phase 4 study testing dexamethasone implant and Ranibizumab in people with Diabetic Macular Edema, run by Far Eastern Memorial Hospital at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetic Macular Edema
What is being tested?
dexamethasone implant and Ranibizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteTaiwan
Study dates
1 Jun 2017to 30 Apr 2019
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • Far Eastern Memorial Hospital

    New Taipei City, 105

Other trials in Taiwan

About this study

Official title: 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.

Read the 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.

Being tested
dexamethasone implant, Ranibizumab
Keywords
dexamethasone implant, vitrectomized, diabetic macular edema, ranibizumab

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • dexamethasone implantDrug

    Also called Dexamethasone implants (Ozurdex®, Allergan Inc., Irvine, CA, USA)

    intravitreal dexamethasone implant injections in vitrectomized patients with DME

  • RanibizumabDrug

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

    intravitreal ranibizumab injections in vitrectomized patients with DME

Study groups in NCT04089605
Study groupRoleWhat they receive
intravitreal dexamethasone implantExperimentalThe 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.
Receives: Drug: dexamethasone implant
intravitreal ranibizumabActive comparatorAs 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.
Receives: Drug: Ranibizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. BCVA at Month 6

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

    Measured: Month 6

  2. CFT at Month 6

    central foveal thickness (CFT) at the end of intervention

    Measured: Month 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Sep 2019
  2. Study start1 Jun 2017
  3. Primary completion1 Nov 2018
  4. Study completion30 Apr 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04089605
Sponsor's protocol ID
105136-E
Status last verified
Sep 2019
First submitted
1 Sep 2019
Last updated
13 Sep 2019
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 27215008

  • 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.

    PubMed 23860753

  • 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.

    PubMed 24227804

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing dexamethasone implant and Ranibizumab in people with Diabetic Macular Edema, run by Far Eastern Memorial Hospital at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

BCVA at Month 6 (time frame: Month 6). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04089605, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2019.

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