Phase 2
N=8
Ranibizumab for Treatment of Persistent Diabetic Neovascularization Assessed by Wide-Field Imaging
Proliferative Diabetic Retinopathy
Bottom Line
View on ClinicalTrials.gov: NCT00606138 ↗Enrolled (actual)
8
Serious AEs
0.0%
Results posted
Nov 2014
Primary outcome: Primary: The Mean Percentage Change of the Area of the Patient's Neovascularization as Measured in Pixels by Optomap FA (Fluorescein Angiography) — -83.8; 52.6; 11.3; 55.4 percentage of change in area (mean)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- ranibizumab (Drug); Laser photocoagulation (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Rush University Medical Center
- Primary completion
- Oct 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Mean Percentage Change of the Area of the Patient's Neovascularization as Measured in Pixels by Optomap FA (Fluorescein Angiography) |
-83.8; 52.6; 11.3; 55.4 | — |
| PRIMARY The Mean Percentage Change of Macular Edema Measured by Retinal Thickness by OCT (Optical Coherence Tomography) |
-2.4; -8.4; 54.1; -2.1 | — |
| PRIMARY Incidence and Severity of Ocular Adverse Events, as Identified by Ophthalmic Examination |
0; 1 | — |
| PRIMARY Number of Participants With Occurrence of Adverse Events |
0; 2 | — |
| SECONDARY Mean Change in Best Corrected Visual Acuity (BCVA), as Assessed by the Number of Lines Gained on the ETDRS Eye Chart at a Starting Test Distance of 4 Meters |
2; 0; 3; 2 | — |
| SECONDARY Percentage of Patients Gaining 3 or More Lines of Vision According to ETDRS Eye Chart Testing |
50.0; 0; 75.0; 33.33 | — |
| SECONDARY Occurrence Rate of Proliferative Diabetic Complications Including Vitreous Hemorrhage, Iris Neovascularization, and Tractional Retinal Detachment |
0; 1 | — |
Summary
Diabetic neovascularization refers to a type of diabetic retinopathy which is worsening by the abnormal growth of blood vessels in the back of the eye, damaging the retina. The usual treatment is a type of laser, called panretinal photocoagulation. One drawback is that the amount of space within the eye for use of this treatment eventually has its limit, and should not be used too near the part of the retina used for detailed vision (the macula). In similar eye disorders, there are certain injectable medications called anti-VEGF treatments which can slow down or stop this abnormal blood vessel growth. This study sought to compare use of ranibizumab versus standard panretinal photocoagulation in treatment of diabetic neovascularization.
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 or older
Patient related considerations:
- Patients with Diabetes Mellitus (Type I or II) are eligible. HgA1c will be evaluated at the beginning of the study, but this value will have no significance in inclusion or exclusion.
- Patients will not be pregnant at enrollment and must provide evidence of the use of two types of birth control while enrolled in the study.
- Patients will have no known sensitivity to ranibizumab or other anti-VEGF injections.
Disease related considerations:
- Patients will have diabetic neovascularization as seen on fluorescein angiography that was previously treated with full (at least 1200 laser burns) panretinal photocoagulation and that has persisted at least three months.
- There will be no evidence of ocular inflammation at enrollment.
- There is no restriction on patient's current medications or concomitant illnesses as long as there is no interference with patient follow-up.
Other considerations:
- Patients may not be enrolled in another clinical study or observational trial.
- There is no limitation on patient's institutional status as long as the patient is able to participate in follow-up.
Exclusion Criteria
- Pregnancy (positive pregnancy test)
- Uncontrolled glaucoma on three medicines or more to control intraocular pressure
- Prior enrollment in the study
- 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
Data sourced from ClinicalTrials.gov (NCT00606138). 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.