Treatment of Residual Diabetic Macular Edema With Ranibizumab
| Status: | Completed |
|---|---|
| Conditions: | Cardiology, Ocular |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Ophthalmology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 11/18/2012 |
| Start Date: | March 2011 |
| End Date: | March 2013 |
| Contact: | Melvin Rabena, BS |
| Email: | mdrabena@yahoo.com |
| Phone: | (805)963-1648 |
Open Label, Phase I/II, Residual Edema Evaluation With 0.5mg and 2.0mg Ranibizumab Formulations (REEF)
This is an open-label, Phase I/II study of intravitreally administered ranibizumab either
0.5-mg and/or 2.0-mg in subjects with clinical, angiographic, and ocular coherence
tomography (OCT) evidence of diabetic retinopathy with associated diabetic macular edema
following bevacizumab therapy. Thirty patients will be enrolled in this study.
Consented, enrolled subjects will receive multiple open-label intravitreal injections of 0.5
mg ranibizumab administered every 30 days (±7 days) for 3 injections during the mandatory
treatment phase (Day 0, Month 1, and Month 2).
Subjects with complete resolution of diabetic macular edema after 3 intravitreal injections
of 0.5 mg ranibizumab will be treated as necessary with 0.5 mg ranibizumab to treat
recurrent macular edema for an additional 9 months (12 months from Day 0). The intent is to
administer additional ranibizumab treatment if there is evidence of disease activity
documented on OCT (e.g., intra-retinal fluid, subretinal fluid and/or cystic changes).
Subjects with residual diabetic macular edema following 3 intravitreal injections of 0.5 mg
ranibizumab will be receive 3 intravitreal injections of 2.0 mg ranibizumab administered
every 30 days (±7 days) for 3 injections at the Month 3, Month 4, and Month 5 study visits.
Beginning at the Month 6 study visit, subjects with complete resolution of diabetic macular
edema following 3 intravitreal injections of 2.0 mg ranibizumab will treated as necessary
with 2.0 mg ranibizumab injections only to treat recurrent macular edema for an additional 6
months (12 months from Day 0).
Subjects with residual diabetic macular edema following 3 consecutive intravitreal
injections of 2.0 mg ranibizumab will be treated as necessary with 2.0 mg ranibizumab to
treat persistent or recurrent macular edema for an additional 6 months (12 months from Day
0). Focal photocoagulation or intravitreal triamcinolone may be administered at the
physician's discretion as an adjunct to ranibizumab injections beginning at Month 6 through
Month 12 of the study.
All subjects will make monthly visits for 12 months for evaluation of safety and efficacy.
All subjects will have their first injection of ranibizumab on Day 0 and undergo a safety
visit one week (±2 days) after the first injection. At subsequent visits, the subject will
have a safety evaluation at the monthly scheduled follow-up visit prior to any intravitreal
injection. Subjects will be contacted by the site personnel 1-2 days after each injection
to elicit reports of decreased vision or pain or unusual new ocular symptoms in the study
eye.
Inclusion Criteria:
- Ability to provide written informed consent and comply with study assessments for the
full duration of the study
- Age > 18 years
- Diagnosis of diabetes mellitus (type 1 or 2)Any one of the following will be
considered to be sufficient evidence that diabetes is present:Current regular use of
insulin for treatment of diabetes or current regular use of oral anti-hyperglycemia
agent for the treatment of diabetes
- Clinical evidence of retinal thickening due to macular edema involving the center of
the macula, associated with diabetic retinopathy.
- Previous history of two consecutive intravitreal bevacizumab injections for the
treatment of diabetic macular edema with documented incomplete resolution of central
subfield thickening by OCT (consecutive injections administered < 7 weeks apart and
within the past 12 months).
- Central diabetic macular edema present on clinical examination and OCT testing with
central 1mm subfield thickness greater than 300 microns as measured on SD-OCT.
- Visual acuity score greater than or equal to 19 letters (20/400) and less than or
equal to 73 letters (20/40) by the ETDRS visual acuity protocol.
- Media clarity, pupillary dilation and patient cooperation sufficient to allow OCT
testing and retinal photography
Exclusion Criteria:
- Pregnancy (positive pregnancy test) or known to be pregnant; also pre-menopausal
women not using adequate contraception.
- Participation in another ocular investigation or trial simultaneously
- Blood pressure > 180/110 (systolic above 180 OR diastolic above 110)
- Any condition that, in the opinion of the investigator, would preclude participation
in the study (e.g. chronic alcoholism, drug abuse)
- Evidence of vitreoretinal interface abnormality after ocular exam or OCT that may be
contributing to the macular edema
- An eye that, in the investigator's opinion, has no chance of improving in visual
acuity following resolution of macular edema (e.g. presence of subretinal fibrosis
or geographic atrophy)
- Presence of another ocular condition that may affect the visual acuity or macular
edema during the course of the study (e.g. AMD, uveitis, Irvine-Gas)
- Evidence of neovascularization of the iris or retina
- Evidence of central atrophy or fibrosis in the study eye
- Presence of substantial cataract, one that might decrease the vision by 3 or more
lines of vision at sometime during the study.
- History of vitreous surgery in the study eye
- History of cataract surgery within 6 months of enrollment.
- History of YAG capsulotomy within 2 months of enrollment.
- Visual acuity <20/400 in the fellow eye
- Uncontrolled glaucoma (pressure >30) despite treatment with glaucoma medications.
- History of cerebral vascular accident or myocardial infarction within 3 months prior
to Day 0.
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