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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Last refreshed on: 3 February 2014
Main ID:  NCT01292798
Date of registration: 07/02/2011
Primary sponsor: California Retina Consultants
Public title: Ranibizumab 0.5mg and 2.0mg to Treat Diabetic Macular Edema in Patients With Poor Response to Bevacizumab REEF
Scientific title: Open Label, Phase I/II, Residual Edema Evaluation With 0.5mg and 2.0mg Ranibizumab Formulations (REEF)
Date of first enrolment: March 2011
Target sample size: 40
Recruitment status: Completed
Study type:  Interventional
Study design:  Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment  
Countries of recruitment
United States
Name:   Dante Pieramici, MD
Affiliation:  California Retina Consultants
Key inclusion & exclusion criteria

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.

Age minimum: 18 Years
Age maximum: N/A
Gender: Both
Health Condition(s) or Problem(s) studied
Diabetic Macular Edema
Drug: Ranibizumab
Primary Outcome(s)
Change in Visual Acuity Scores at Month 12 Compared to Baseline [Time Frame: 12 months]
Secondary Outcome(s)
Change in Central Retinal Thickness as Measured by OCT at Month 12 Compared to Baseline [Time Frame: 12 months]
Number of participants with ocular and systemic adverse events as a measure of safety and tolerability. [Time Frame: 12 months]
Participant Scores on Work Productivity and Activity Impairment Questionnaire [Time Frame: Baseline, Month 3 and Month 12]
Qualitative Assessment of Diabetic Macular Edema [Time Frame: 12 months]
Secondary ID(s)
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
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