Phase 2
N=20
Dosing Study of Ranibizumab for Diabetic Retinal and Macular Edema
Diabetic Retinopathy · Macular Edema
Bottom Line
View on ClinicalTrials.gov: NCT01476449 ↗Enrolled (actual)
20
Serious AEs
20.0%
Results posted
May 2019
Primary outcome: Primary: Mean Change in Early Treatment for Diabetic Retinopathy Study (ETDRS) Eye Chart Vision. — 8.3; 8.5 ETDRS Letters
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Ranibizumab (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Retina Vitreous Associates of Florida
- Primary completion
- Sep 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change in Early Treatment for Diabetic Retinopathy Study (ETDRS) Eye Chart Vision. |
8.3; 8.5 | — |
| SECONDARY Mean Number of Injections. |
19.4; 18.8 | — |
| SECONDARY Mean Change in Spectral Domain Optical Coherence Tomography (SD-OCT) Central Foveal Thickness (CFT). |
-169.0; -146.8 | — |
| SECONDARY Percentage of Patients With Best Corrected Visual Acuity (BCVA) Snellen-equivalent of 20/40 or Better. |
10; 9 | — |
| SECONDARY Percentage of Patients Anatomically "Dry." |
8; 7 | — |
Summary
This study is to see whether treating diabetic retinal swelling with ranibizumab injections into the eye monthly is better than treating diabetic retinal swelling with ranibizumab injections into the eye less frequently.
Eligibility Criteria
Inclusion Criteria
- Ability to provide written informed consent and comply with study assessments for the full duration of the study
- Age > 18 years
- Patient related considerations
- Phakic or pseudophakic patients with a known history of diabetes will be eligible.
- Women of reproductive age will be required to take a urine pregnancy test prior to administration of the study drug.
- Disease related considerations:
- Patients will have met standard, accepted diagnostic criteria for diabetes and will be currently treated with at least one systemic antihyperglycemic or insulin medication.
- Patients will have a BCVA ETDRS Snellen-equivalent less than or equal to 20/40
- Central foveal thickness on SD-OCT of >300um
Exclusion Criteria
- Pregnancy (positive pregnancy test) or lactation Premenopausal women not using adequate contraception. The following are considered effective means of contraception: surgical sterilization or use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel, an IUD, or contraceptive hormone implant or patch.
- Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated
- Participation in another simultaneous medical investigation or trial
- Foveal ischemia on IVFA
- Intraocular surgery less than 6 months ago
- Epiretinal membrane of clinical significance
- Prior vitrectomy
- Uncontrolled glaucoma
- Macular or peripheral laser within 90 Days from Day 0 injection
- Intravitreal steroid injection within 90 days from Day 0 injection
- Intravitreal or systemic anti-VEGF within 30 days from Day 0 injection
Data sourced from ClinicalTrials.gov (NCT01476449). 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.