Phase 2
Completed N=101
Evaluation of Inflammation and Pain Post Injection of Ranibizumab vs Aflibercept in Patients With DME
Source: ClinicalTrials.gov NCT02363621 ↗Enrolled (actual)
101
Serious AEs
0.0%
Results posted
Apr 2019
Primary outcomePrimary: Number of Participants With Intraocular Inflammation — 6; 10 Participants
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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 | — |
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.
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. Informational only — not medical advice.