NCT02471651

Brief Summary

Laser photocoagulation and intravitreal anti-vascular growth factor injections are commonly used treatment options for individuals with diabetic macular edema. However, some patients continue to experience persistent diabetic macular edema and poor vision despite continued laser and/or anti-vegf therapy. Recent clinical trials suggest that due to inflammatory mediators dexamethasone intravitreal implant (0.7mg) may be a good alternative therapy for individuals unresponsive to laser photocoagulation or intravitreal anti-vascular growth factor injections. The purpose of this research study is to compare the effectiveness of using a dexamethasone steroid implant versus monthly intravitreal anti-VEGF injections for research participants with persistent diabetic macular edema (DME).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jun 2015

Typical duration for phase_4

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

June 11, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 15, 2015

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 24, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 24, 2018

Completed
4 months until next milestone

Results Posted

Study results publicly available

February 19, 2019

Completed
Last Updated

February 19, 2019

Status Verified

January 1, 2019

Enrollment Period

3.4 years

First QC Date

June 11, 2015

Results QC Date

January 2, 2019

Last Update Submit

January 29, 2019

Conditions

Diabetic Macular Edema

Outcome Measures

Primary Outcomes (1)

  • Mean Change in Central 1 mm Subfield Thickness Between Baseline and 9 Months

    Mean change in central 1 mm sub-field thickness between baseline and 9 months as measured by Spectral Domain Optical Coherence Tomography (SDOCT).

    baseline and 9 months

Secondary Outcomes (2)

  • Mean Change in Standardized Best-corrected Visual Acuity (BCVA) Between Baseline and 9 Months

    baseline and 9 months

  • Total Number of Treatments in Each Arm Between Baseline and 9 Months

    baseline and 9 months

Study Arms (2)

Implant

ACTIVE COMPARATOR

Subjects randomized to dexamethasone intravitreal implant (0.7mg) will receive the initial treatment at Month 3 (visit 4) and Month 6 (visit 7) and are eligible to receive one additional dose at Month 9 (visit 10), Month 10 (visit 11) or Month 11 (visit 12) for persistent or recurrent macular edema documented on SDOCT. If dexamethasone intravitreal implant (0.7mg) is administered at Month 10 (visit 11) or Month 11 (visit 12) an additional safety study visit will be required at one to two months following Month 12 (visit 13). The investigator can withhold treatment with dexamethasone intravitreal implant (0.7mg) beginning at Month 9 if there is complete resolution of diabetic macular edema document on SDOCT.

Drug: Dexamethasone intravitreal implant (0.7 mg)

Intravitreal anti-VEGF injection

ACTIVE COMPARATOR

Subjects randomized to continue on anti-vegf therapy will receive intravitreal anti-vegf injections at Month 3 (visit 4) Month 4 (visit 5) and Month 5 (visit 6). Beginning at Month 6 (visit 7), subjects who have received 6 intravitreal anti-vegf injections and continue to present with persistent diabetic macular edema defined as less than 10% reduction or any increase in CST compared to baseline values and CST is greater than 300 microns, will receive dexamethasone intravitreal implant (0.7mg) at Month 6 (visit 7) and Month 9 (visit 10). The follow-up period for all subjects will continue through 12 months from the baseline study visit.

Drug: Intravitreal anti-VEGF injection

Interventions

Dexamethasone intravitreal implant (0.7 mg)DRUG

Subjects with persistent DME who are randomized to this arm may get up to 3 treatments with the implant (0.7 mg dexamethasone).

Also known as: Ozurdex
Implant
Intravitreal anti-VEGF injectionDRUG

This injection may be ranibizumab, bevacizumab, or aflibercept.

Also known as: ranibizumab, bevacizumab, or aflibercept
Intravitreal anti-VEGF injection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Able to provide written informed consent and comply with study assessments for the full duration of the study.
  • Age ≥ 18 years
  • Diagnosis of diabetes mellitus (type 1 or 2)
  • Any one of the following will be considered to be sufficient evidence that diabetes is present:
  • Current regular use of insulin for treatment of diabetes
  • Current regular use of oral anti-hyperglycemia agent for the treatment of diabetes
  • Clinical evidence of retinal thickening due to macular edema involving the center of the macula associated with diabetic retinopathy.
  • Previous history of anti-vegf treatment for diabetic macular edema (DME) with documented incomplete resolution of central subfield thickening by spectral-domain optical coherence tomography (SDOCT). At least 4 intravitreal anti-vegf injections within the past six months prior to the baseline study visit are required for eligibility.
  • Central diabetic macular edema present on clinical examination and SDOCT testing with central 1 mm subfield thickness greater than 300 microns as measured on SDOCT at the baseline visit.
  • Visual acuity score greater than or equal to 19 letters (20/400) and less than or equal to 74 letters (20/32) by the ETDRS visual acuity protocol.
  • Media clarity, pupillary dilation and patient cooperation sufficient to allow SDOCT testing and retinal photography.

You may not qualify if:

  • Pregnancy (positive pregnancy test) or known to be pregnant; also pre-menopausal women not using adequate contraception.
  • Participation in another ocular investigation or trial simultaneously
  • Blood pressure \> 180/110 mmHg (systolic above 180 OR diastolic above 110 mmHg)
  • Any condition that, in the opinion of the investigator, would preclude participation in the study (e.g. chronic alcoholism, drug abuse)
  • Evidence of vitreoretinal interface abnormality after ocular exam or OCT that may be contributing to the macular edema
  • An eye that, in the investigator's opinion, has no chance of improving in visual acuity following resolution of macular edema (e.g. presence of subretinal fibrosis or geographic atrophy)
  • Presence of another ocular condition that may affect the visual acuity or macular edema during the course of the study (e.g. AMD, uveitis, Irvine-Gass)
  • Evidence of active neovascularization of the iris or retina
  • Evidence of central atrophy or fibrosis in the study eye
  • Presence of substantial cataract, one that might decrease the vision by 3 or more lines of vision at sometime during the study.
  • History of vitreous surgery in the study eye
  • History of cataract surgery within 3 months of enrollment.
  • History of YAG capsulotomy within 2 months of enrollment.
  • Visual acuity \<20/400 on ETDRS visual acuity charts in the fellow eye
  • Uncontrolled glaucoma (pressure \> 30 mmHg) despite treatment with glaucoma medications.
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

California Retina Consultants

Bakersfield, California, 93309, United States

Location

California Retina Consultants

Oxnard, California, 93030, United States

Location

California Retina Consultants

Santa Barbara, California, 93103, United States

Location

California Retina Consultants

Santa Maria, California, 93454, United States

Location

Related Publications (1)

  • Chakravarthy H, Devanathan V. Molecular Mechanisms Mediating Diabetic Retinal Neurodegeneration: Potential Research Avenues and Therapeutic Targets. J Mol Neurosci. 2018 Nov;66(3):445-461. doi: 10.1007/s12031-018-1188-x. Epub 2018 Oct 6.

    PMID: 30293228DERIVED

MeSH Terms

Interventions

DexamethasoneCalcium DobesilateRanibizumabBevacizumabaflibercept

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedBenzenesulfonatesBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsArylsulfonatesArylsulfonic AcidsSulfonic AcidsSulfur AcidsSulfur CompoundsAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Results Point of Contact

Title
Dr. Gabriel Gordon
Organization
California Retina Consultants
gabe@californiaretina.com
8059631648

Study Officials

  • Gabriel Gordon, Ph.D.

    California Retina Consultants

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2015

First Posted

June 15, 2015

Study Start

June 1, 2015

Primary Completion

October 24, 2018

Study Completion

October 24, 2018

Last Updated

February 19, 2019

Results First Posted

February 19, 2019

Record last verified: 2019-01

Locations

US(4)