Clinical trial NCT02363621: Evaluation of Inflammation and Pain Post Injection of Ranibizumab vs Aflibercept in Patients With DME
Official title: Evaluation of Inflammation and Pain Post Injection of Ranibizumab vs. Aflibercept in Patients With Diabetic Macular Edema
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetic Macular Edema
Lead sponsor: Sierra Eye Associates
Sponsor class: OTHER
Collaborators: name: Genentech, Inc.
First posted: 2015-02-16
Enrollment: 101
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Detailed description: This is an open-label, Phase II study of post injection pain and inflammation after intravitreally administered ranibizumab and aflibercept in 100 subjects with Diabetic Macular Edema. Treatment naïve and experienced patients will be enrolled. Treatment experienced patients with history of anti-vegf injections will be eligible as long as they have not received any intravitreal injection in the 3 months prior to the study visit. Patients will be randomized to receive either Lucentis 0.3 mg or Eylea 2.0 mg, and followed for a week. A non-injecting masked physician who is blinded to the treatment drug will evaluate the patient at baseline before the injection and then within 1-2 days and 5-7 days after the injection for anterior chamber and vitreous cells using slit lamp examination and indirect ophthalmoscopy. Pain will also be recorded at these visits using a standardized pain scale.

Consented, enrolled subjects will receive open-label intravitreal injection of either 0.3 mg ranibizumab or 2.0 mg aflibercept. A standard intravitreal injection protocol will be followed. Patients will be revaluated at baseline, 1-2 days and 5-7 days post injections. A non-injecting physician will evaluate the patients for anterior chamber and vitreous inflammation; this physician will be blinded about the specific treatment. Anterior chamber inflammation is described as any cell or flare in the anterior chamber. These will be evaluated using Standardization of Uveitis Nomenculature (SUN) working group classifications. Pain score will be evaluated using a Numerical Rating 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.

Primary outcomes:
measure: Number of Participants With Intraocular Inflammation
timeFrame: 24 to 48 hours (visit #1)
measure: Number of Participants With Intraocular Inflammation
timeFrame: 5 to 7 days (visit #2)
Secondary outcomes:
measure: Number of Participants With Post Injection Pain Above 0 on a 11 Point Pain Scale.
timeFrame: 24 to 48 hours visit #1 and 5 to 7 days visit #2
Other outcomes:
Locations:
city: Reno
country: United States
facility: Sierra Eye Associates
state: Nevada
Study officials:
affiliation: Sierra Eye Associates
name: Arshad Khanani, MD
role: PRINCIPAL_INVESTIGATOR
References: