NCT02363621

Brief Summary

This study is designed to compare the post injection inflammation and pain seen after intravitreal injections of ranibizumab 0.3mg and aflibercept 2.0mg in patients with DME. The investigators will be evaluating patients (1-7 days) post injections for: 1\. Intraocular inflammation (defined as anterior chamber and/or vitreous cells 2. Pain (as measured on a standardized pain scale).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
101

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2015

Geographic Reach
1 country

1 active site

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

January 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 2, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 16, 2015

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

April 26, 2019

Completed
Last Updated

April 26, 2019

Status Verified

April 1, 2019

Enrollment Period

2.8 years

First QC Date

February 2, 2015

Results QC Date

November 4, 2018

Last Update Submit

April 2, 2019

Conditions

Diabetic Macular Edema

Outcome Measures

Primary Outcomes (2)

  • Number of Participants With Intraocular Inflammation

    Number of participants with intraocular inflammation as seen on slide lamp and dilated fundus exam.

    24 to 48 hours (visit #1)

  • Number of Participants With Intraocular Inflammation

    Number of Participants With Intraocular Inflammation as seen on slit lamp and dilated fundus exam

    5 to 7 days (visit #2)

Secondary Outcomes (1)

  • Number of Participants With Post Injection Pain Above 0 on a 11 Point Pain Scale.

    24 to 48 hours visit #1 and 5 to 7 days visit #2

Study Arms (2)

Ranibizumab 0.3 Intravitreal injection

ACTIVE COMPARATOR

Intravitreal injection of Ranibizumab 0.3 mg once

Drug: Ranibizumab 0.3 mg

Aflibercept 2.0 mg intravitreal injection

ACTIVE COMPARATOR

Intravitreal Aflibercept 2.0 mg once

Drug: Aflibercept 2.0 mg

Interventions

Ranibizumab 0.3 mgDRUG

Ranibizumab 0.3 mg Patient will receive intravitreal injection of Ranibizumab 0.3 mg

Also known as: Lucentis
Ranibizumab 0.3 Intravitreal injection
Aflibercept 2.0 mgDRUG

Patient will receive intravitreal injection of Aflibercept 2.0 mg

Also known as: Eylea
Aflibercept 2.0 mg intravitreal injection

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects will be eligible if the following criteria are met:
  • Ability to provide written informed consent and comply with study assessments for the full duration of the study
  • Age \> 21 years
  • Exam and OCT confirming Diabetic Macular Edema
  • Visual Acuity of 20/400 or better
  • No history of post injection pain or inflammation in the past

You may not qualify if:

  • Subjects who meet any of the following criteria will be excluded from this study
  • History of Endophthalmitis in either eye
  • Current inflammation in either eye
  • Uncontrolled or symptomatic Dry Eye Syndrome
  • Intravitreal injection less than 3 months ago
  • History of Anterior or Posterior Uveitis
  • History of post injection pain with prior treatments
  • Recent thromboembolic event (\<3 months)
  • Pregnancy (positive pregnancy test) or lactation
  • Premenopausal women not using adequate contraception.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sierra Eye Associates

Reno, Nevada, 89502, United States

Location

MeSH Terms

Interventions

Ranibizumabaflibercept

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Results Point of Contact

Title
Dr. Arshad Khanani
Organization
Sierra Eye Associates
Arshad.Khanani@gmail.com
775-329-0286

Study Officials

  • Arshad Khanani, MD

    Sierra Eye Associates

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Vitreo-Retinal Diseases and Surgery

Study Record Dates

First Submitted

February 2, 2015

First Posted

February 16, 2015

Study Start

January 1, 2015

Primary Completion

October 1, 2017

Study Completion

October 1, 2017

Last Updated

April 26, 2019

Results First Posted

April 26, 2019

Record last verified: 2019-04

Locations

US(1)