Evaluation of Inflammation and Pain Post Injection of Ranibizumab vs. Aflibercept in Patients With Diabetic Macular Edema
| Status: | Completed |
|---|---|
| Conditions: | Cardiology, Ocular |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Ophthalmology |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 10/29/2017 |
| Start Date: | January 2015 |
| End Date: | October 2017 |
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).
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).
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.
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.
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.
We found this trial at
1
site
Reno, Nevada 89502
Principal Investigator: Arshad M Khanani, MD
Phone: 775-329-0286
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