NCT02059772

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Apr 2014

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 10, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 11, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

April 30, 2014

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2017

Completed
Last Updated

February 23, 2017

Status Verified

February 1, 2017

Enrollment Period

3.5 years

First QC Date

February 10, 2014

Last Update Submit

February 21, 2017

Conditions

Diabetic Macular Edema

Outcome Measures

Primary Outcomes (1)

  • change in best corrected visual acuity (BCVA)

    baseline, 12 month

Secondary Outcomes (2)

  • change in central macular thickness

    baseline, 12 month

  • number of intravitreal Lucentis injections

    within 12 month

Study Arms (2)

Control Group

EXPERIMENTAL

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

Drug: ranibizumab

Treatment Group

EXPERIMENTAL

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

Drug: ranibizumabProcedure: micropulse diode laser

Interventions

ranibizumabDRUG
Also known as: Lucentis
Control GroupTreatment Group
micropulse diode laserPROCEDURE
Treatment Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klinik für Augenheilkunde, Klinikum Chemnitz gGmbH

Chemnitz, 09116, Germany

Location

Related Publications (1)

  • 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.

    PMID: 32727496DERIVED

MeSH Terms

Interventions

Ranibizumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Klio Ai Becker, MD

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 10, 2014

First Posted

February 11, 2014

Study Start

April 30, 2014

Primary Completion

November 1, 2017

Study Completion

December 31, 2017

Last Updated

February 23, 2017

Record last verified: 2017-02

Locations

DE(1)