Combination of Standard Lucentis Therapy With Micropulse Diode Laser for the Treatment of Diabetic Macular Edema
NCT ID: NCT02059772
Last Updated: 2017-02-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
25 participants
INTERVENTIONAL
2014-04-30
2017-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Control Group
Standard therapy of diabetic macular edema with Lucentis (ranibizumab) according to SmPC
ranibizumab
Treatment Group
Combination of standard therapy of Lucentis (ranibizumab) according to SmPC and micropulse diode laser treatment
ranibizumab
micropulse diode laser
Interventions
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ranibizumab
micropulse diode laser
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* BCVA between 0.05 and 0.6 or retinal thickness \> 300 µm determined by SD-OCT
* The informed consent form must be signed before any study specific tests or procedures are done
* Confirmation of the subject's health insurance coverage prior to the first screening visit
* Age at least 18 years (inclusive) at the first screening visit
* Ability to understand and follow study-related instructions
Exclusion Criteria
* Active neovascularization of iris or retina in the study eye
* History of intravitreal injection of VEGF-inhibitor or steroids in study eye within the last 3 month
* Pathologies of the anterior segment of the study eye with reduced visual acuity (e.g. corneal opacification, advanced cataract)
* Advanced glaucoma with central defects of the visual field in study eye
* Retinal pathologies with reduced visus (e.g. central scars, age related macular degeneration) in study eye
* Retinal vascular occlusion in medical history of study eye
* Active or suspected ocular or periocular infections
* Active intraocular inflammation in study eye
* Intraocular surgery of study eye within the last 6 months
* Laser therapy of study eye within the last 6 months
* Systemic steroid therapy within the last 3 month
* HbA1c \>10%
* Systolic blood pressure above 170 mmHg and diastolic blood pressure above 110 mmHg (after at least 3 min in supine position)
* Pregnant or breast-feeding woman and woman without adequate method of contraception.
* Known hypersensitivity to the active substance or to any of the excipients
18 Years
ALL
No
Sponsors
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Novartis
INDUSTRY
GWT-TUD GmbH
OTHER
Responsible Party
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Principal Investigators
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Klio Ai Becker, MD
Role: STUDY_CHAIR
Locations
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Klinik für Augenheilkunde, Klinikum Chemnitz gGmbH
Chemnitz, , Germany
Countries
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References
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Furashova O, Strassburger P, Becker KA, Engelmann K. Efficacy of combining intravitreal injections of ranibizumab with micropulse diode laser versus intravitreal injections of ranibizumab alone in diabetic macular edema (ReCaLL): a single center, randomised, controlled, non-inferiority clinical trial. BMC Ophthalmol. 2020 Jul 29;20(1):308. doi: 10.1186/s12886-020-01576-w.
Other Identifiers
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ReCaLL-2013
Identifier Type: -
Identifier Source: org_study_id
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