Evaluation of Inflammation and Pain Post Injection of Ranibizumab vs Aflibercept in Patients With DME

Part of paid clinical trials in Reno, Nevada.

Sponsor
Arshad Khanani
Study ID
NCT02363621
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
21 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Ranibizumab 0.3 mg — DRUG
    Ranibizumab 0.3 mg Patient will receive intravitreal injection of Ranibizumab 0.3 mg
  • Aflibercept 2.0 mg — DRUG
    Patient will receive intravitreal injection of Aflibercept 2.0 mg

Study Details

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).

Key Dates

Start date
Jan 31, 2015
Status verified
Apr 2019
Primary completion
Oct 31, 2017
Completion
Oct 31, 2017

Study Design

Enrollment
101 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Ranibizumab 0.3 Intravitreal injection
    Intravitreal injection of Ranibizumab 0.3 mg once
  • Active Comparator: Aflibercept 2.0 mg intravitreal injection
    Intravitreal Aflibercept 2.0 mg once

Primary Outcome Measure

Number of Participants With Intraocular Inflammation [ Time Frame: 24 to 48 hours (visit #1) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Sierra Eye AssociatesRenoNevada89502-

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