NCT00994955

Brief Summary

Selective Retina Therapy (SRT) is an effective and safe laser treatment of clinically significant diabetic macular edema which targets the retinal pigment epithelium while sparing the neurosensory retina.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
39

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jan 2006

Typical duration for phase_1

Status
completed

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

Study Start

First participant enrolled

January 1, 2006

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

October 13, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 14, 2009

Completed
Last Updated

January 16, 2013

Status Verified

January 1, 2013

Enrollment Period

2.9 years

First QC Date

October 13, 2009

Last Update Submit

January 15, 2013

Conditions

Diabetic Macular Edema

Keywords

SRTlaserdiabetic macular edemadiabetesClinically significant diabetic macular edema

Outcome Measures

Primary Outcomes (1)

  • best-corrected visual acuity

    2 years

Secondary Outcomes (1)

  • change of retinal thickness, presence of hard exudates and leakage in FFA, specificity and sensitivity of optoacoustic measurements

    2 years

Study Arms (1)

selective retina therapy (SRT)

EXPERIMENTAL

Focal laser treatment with an SRT-Laser which selectively affects the retinal pigment epithelium while sparing the photoreceptor layer.

Device: selective retina therapy (SRT)

Interventions

selective retina therapy (SRT)DEVICE

laser treatment

selective retina therapy (SRT)

Eligibility Criteria

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

You may qualify if:

  • Minimum age of 18 years and the presence of clinically significant DME according to the criteria of the ETDRS study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Jost Hillenkamp, MD

    Dept. of Ophthalmology, University Medical Center Schleswig-Holstein, Kiel Campus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Oberarzt, Dept. of Ophthalmology, University of Schleswig-Holstein, Kiel, Germany

Study Record Dates

First Submitted

October 13, 2009

First Posted

October 14, 2009

Study Start

January 1, 2006

Primary Completion

December 1, 2008

Study Completion

October 1, 2009

Last Updated

January 16, 2013

Record last verified: 2013-01