Phase 2 N=101 Randomized Single-blind Treatment

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

Diabetic Macular Edema

Bottom Line

View on ClinicalTrials.gov: NCT02363621 ↗

Enrolled (actual)

101

Serious AEs

0.0%

Results posted

Apr 2019

Primary outcome: Primary: Number of Participants With Intraocular Inflammation — 6; 10 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Ranibizumab 0.3 mg (Drug); Aflibercept 2.0 mg (Drug)
Age: Adult, Older Adult · 21+ yrs
Sex: All
Sponsor: Arshad Khanani
Primary completion: Oct 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Intraocular Inflammation	1; 3	—
PRIMARY Number of Participants With Intraocular Inflammation	1; 3	—
SECONDARY Number of Participants With Post Injection Pain Above 0 on a 11 Point Pain Scale.	28; 28; 10; 5	—

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).

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02363621). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.