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

Diabetic Macular Edema Clinical Trial

— ReCaLL  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02059772
• Other study ID #: ReCaLL-2013
• Status: Active, not recruiting
• Phase: Phase 4
• First received: February 10, 2014
• Last updated: February 21, 2017
• Start date: April 30, 2014
• Est. completion date: December 31, 2017

Study information

• Verified date: February 2017
• Source: GWT-TUD GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 25
• Est. completion date: December 31, 2017
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Edema
• Macular Edema

Intervention

Drug:
• ranibizumab

Procedure:
• micropulse diode laser

Locations

Country	Name	City	State
Germany	Klinik für Augenheilkunde, Klinikum Chemnitz gGmbH	Chemnitz

Sponsors (2)

Lead Sponsor	Collaborator
GWT-TUD GmbH	Novartis

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in best corrected visual acuity (BCVA)		baseline, 12 month
Secondary	change in central macular thickness		baseline, 12 month
Secondary	number of intravitreal Lucentis injections		within 12 month