Clinical trial NCT02059772: Combination of Standard Lucentis Therapy With Micropulse Diode Laser for the Treatment of Diabetic Macular Edema
Official title: Evaluation of an Additional Therapeutic Approach to Diabetic Macular Edema by Combining Standard Therapy (Intravitreal Injection of a VEGF-inhibitor) With Micropulse Diode Laser Treatment in a Randomized, Controlled Proof of Concept Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Diabetic Macular Edema
Lead sponsor: GWT-TUD GmbH
Sponsor class: OTHER
Collaborators: name: Novartis
First posted: 2014-02-11
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).


Eligibility criteria: 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

Primary outcomes:
measure: change in best corrected visual acuity (BCVA)
timeFrame: baseline, 12 month
Secondary outcomes:
measure: change in central macular thickness
timeFrame: baseline, 12 month
measure: number of intravitreal Lucentis injections
timeFrame: within 12 month
Other outcomes:
Locations:
city: Chemnitz
country: Germany
facility: Klinik für Augenheilkunde, Klinikum Chemnitz gGmbH
Study officials:
name: Klio Ai Becker, MD
role: STUDY_CHAIR
References:
citation: 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.