NCT00427986

Brief Summary

The purpose of the present study is to examine, if retinal swelling in diabetic patients can be reduced by an intravenous injection of galactose.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
1

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2007

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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, 2007

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

January 25, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 29, 2007

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
Last Updated

June 26, 2007

Status Verified

June 1, 2007

First QC Date

January 25, 2007

Last Update Submit

June 25, 2007

Conditions

Diabetic Macular Oedema

Keywords

DiabetesMacular oedemaOsmosisGalactoseIntravenousRetinal thicknessStarling

Outcome Measures

Primary Outcomes (1)

  • Retinal thickness estimated by the fast protocol of the StratusOCT (0, 2, 4, 8, 10, 15, 20, 30, 60, 90, 120 and 180 min).

    three hours

Secondary Outcomes (1)

  • Side effects during the three-hour examination period, to evaluate if caused by galactose per se or by an increase in intracapillary osmotic pressure.

    Three hours

Interventions

Galactose, intravenousDRUG

Eligibility Criteria

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

You may qualify if:

  • Type 1 or type 2 diabetes
  • clinically significant macular oedema
  • visual acuity of minimum 40 letters by the ETDRS procedure
  • retinal thickness of at least 250 microns in the foveal region on three retinal maps of the fast protocol of the StratusOCT at baseline or at least 300 microns outside the foveal region
  • disc area of oedema within 3000 microns from the foveal center on three retinal maps of the fast protocol of the StratusOCT at baseline
  • maximal blood pressure 160/90 mmHg (mean of three measurements)
  • informed consent

You may not qualify if:

  • other ocular diseases or treatments, that can cause or influence the macular oedema, including prior laser photocoagulation. Traction oedema is allowed.
  • glaucoma
  • media opacities that significantly impairs the light reflection while scanning
  • Pregnancy
  • severe heart, lung and/or renal insufficiency (judged by the primary investigator)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Ophthalmology, Glostrup Hospital, University of Copenhagen, Nordre Ringvej 57,

Glostrup Municipality, DK-2600, Denmark

Location

MeSH Terms

Conditions

Diabetes MellitusMacular Edema

Interventions

Galactose

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesMacular DegenerationRetinal DegenerationRetinal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

HexosesMonosaccharidesSugarsCarbohydrates

Study Officials

  • Dorte Nellemann Thornit, MD

    Department of Ophthalmology, Glostrup Hospital, University of Copenhagen, Nordre Ringvej 57, DK-2600 Glostrup, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 25, 2007

First Posted

January 29, 2007

Study Start

January 1, 2007

Study Completion

March 1, 2007

Last Updated

June 26, 2007

Record last verified: 2007-06

Locations

DK(1)