Phase 2 N=100 Single-blind Treatment

Evaluation of Pain and Inflammation After Injection of Lucentis vs Eylea for Treatment of Wet Macular Degeneration

Neovascular Age-Related Macular Degeneration

Bottom Line

View on ClinicalTrials.gov: NCT01926977 ↗

Enrolled (actual)

100

Serious AEs

0.0%

Results posted

Mar 2016

Primary outcome: Primary: Evidence of Anterior Chamber Inflammation — 1; 10; 0; 1 participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Ranibizumab 0.5mg (Drug); Aflibercept 2.0mg (Drug)
Age: Older Adult · 65+ yrs
Sex: All
Sponsor: Arshad Khanani
Primary completion: May 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Evidence of Anterior Chamber Inflammation	1; 10; 0; 1	—
SECONDARY Patients With Post Injection Pain Score of One or Higher on Pain Scale	7; 9; 0; 1	—

Summary

This study is designed to compare the post injection inflammation and pain seen after intravitreal injections of Ranibizumab vs Aflibercept.

Eligibility Criteria

Inclusion Criteria

Able to provide informed consent and comply with study assessments for the full duration of the study
Age >/= 65 years
New onset Neovascular Age-Related Macular Degeneration or (See No.4)
Previously treated Neovascular Age-Related Macular Degeneration with Lucentis or Eylea intravitreal injections
Visual Acuity of 20/400 or better
No history of Post injection pain or inflammation with prior treatments -

Exclusion Criteria

History of Endophthalmitis in either eye
Uncontrolled or symptomatic Dry Eye Syndrome
History of Anterior or Posterior Uveitis
History of Post injection pain or inflammation 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 (NCT01926977). 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.