Combination of Standard Lucentis Therapy With Micropulse Diode Laser for the Treatment of Diabetic Macular Edema (ReCaLL)

GWT-TUD

Status and phase: Unknown; Phase 4

Conditions: Diabetic Macular Edema

Treatments: Procedure: micropulse diode laser; Drug: ranibizumab

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02059772

ReCaLL-2013

Details and patient eligibility

About

The primary objective of this study is to evaluate if a combination therapy with micropulse diode laser treatment shows non inferiority on visual acuity within 12 months in comparison to standard therapy (intravitreal injection of ranibizumab only).

Enrollment: 25 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of non-ischemic diabetic macular edema with resulting reduction in visual functionality by determination of best corrected visual acuity (BCVA), ophthalmologic investigation, SD-OCT, FAG and anamnesis
• 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

• Severe ischemic maculopathy of the study eye
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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25 participants in 2 patient groups

Control Group

Experimental group

Description:

Standard therapy of diabetic macular edema with Lucentis (ranibizumab) according to SmPC

Treatment:

Drug: ranibizumab

Treatment Group

Experimental group

Description:

Combination of standard therapy of Lucentis (ranibizumab) according to SmPC and micropulse diode laser treatment

Treatment:

Procedure: micropulse diode laser

Drug: ranibizumab