NCT04067856

Brief Summary

The purpose of this research is to compare the effectiveness of bevacizumab (Avastin) with another a dexamethasone implant (Ozurdex), with respect to anatomic and visual outcomes as well as injection frequency in subjects undergoing cataract surgery with a concurrent diagnosis of diabetic macular edema (DME).

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2020

Status
withdrawn

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

First Submitted

Initial submission to the registry

August 22, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 28, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2021

Completed
Last Updated

February 21, 2021

Status Verified

February 1, 2021

Enrollment Period

1.1 years

First QC Date

August 22, 2019

Last Update Submit

February 17, 2021

Conditions

Diabetic Macular EdemaCataract

Outcome Measures

Primary Outcomes (1)

  • Final visual acuity

    6 month

Secondary Outcomes (2)

  • Final optical coherence tomography central macular thickness

    6 month

  • Total number of intravitreal injections over study period

    6 month

Study Arms (2)

Bevacizumab

ACTIVE COMPARATOR

Intravitreal injection of 1.25mg/0.05cc bevacizumab

Drug: Bevacizumab Injection

Dexamethasone implant

ACTIVE COMPARATOR

Intravitreal injection of 0.7mg dexamethasone implant

Drug: Bevacizumab Injection

Interventions

Bevacizumab InjectionDRUG

Intravitreal injection

Also known as: dexamethasone implant injection
BevacizumabDexamethasone implant

Eligibility Criteria

Age18 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age greater than 18 years old with type one or type two diabetes mellitus
  • Center-involving diabetic macular edema with central subfield thickness ≥ 320um on Heidelberg Spectralis optical coherence tomography (OCT) testing
  • Best-corrected electron-early treatment diabetic retinopathy study (E-ETDRS Visual Acuity) visual acuity letter score between 78 to 24
  • Any Lens Opacities Classification System (LOCS) III cataract grade greater than or equal to two

You may not qualify if:

  • Presence of macular edema attributable to other causes including but not limited to retinal venous occlusive disease and non-infectious uveitis
  • History of glaucoma
  • History of steroid-induced intraocular pressure (IOP) elevation that required IOP-lowering treatment
  • Optic nerve cup to disc ratio greater than 0.6
  • Active proliferative diabetic retinopathy
  • Presence of other retinal diseases including but not limited to age-related macular degeneration, retinal venous occlusive disease and posterior segment uveitis
  • Any prior intraocular surgery
  • Treatment with any anti-VEGF medication within the past 3 months or intravitreal steroid within the past 6 months
  • Panretinal photocoagulation within the prior 6 months or anticipated need for panretinal photocoagulation within the next 6 months
  • IOP greater than or equal to 25
  • Systolic blood pressure \> 180 mmHg or diastolic \> 110 mmHg
  • Myocardial infarction, other cardiac event requiring hospitalization, cerebrovascular accident, transient ischemic attack or treatment for acute congestive heart failure within the past 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cataract

Interventions

BevacizumabDexamethasone

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsPregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Clinical Professor of Ophthalmology, UCLA

Study Record Dates

First Submitted

August 22, 2019

First Posted

August 28, 2019

Study Start

January 1, 2020

Primary Completion

January 31, 2021

Study Completion

January 31, 2021

Last Updated

February 21, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share