NCT01208948

Brief Summary

To evaluate the effect of alpha lipoic acid (ALA) on the occurrence of diabetic macular edema.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
520

participants targeted

Target at P75+ for phase_3 diabetes-mellitus

Timeline
Completed

Started Jul 2000

Longer than P75 for phase_3 diabetes-mellitus

Geographic Reach
1 country

1 active site

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

July 1, 2000

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2005

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
4.8 years until next milestone

First Submitted

Initial submission to the registry

September 23, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 24, 2010

Completed
Last Updated

September 24, 2010

Status Verified

September 1, 2010

Enrollment Period

4.8 years

First QC Date

September 23, 2010

Last Update Submit

September 23, 2010

Conditions

Diabetes MellitusMacular Edema

Keywords

macular edemadiabetes mellitusprevention alpha lipoic acid

Outcome Measures

Primary Outcomes (1)

  • occurrence of clinically significant macular edema (CSME) within a follow-up period of 2 years

    two years

Secondary Outcomes (1)

  • The time to CSME development

    two years

Study Arms (2)

Alpha lipoic acid 600 mg

ACTIVE COMPARATOR
Drug: 1,2 dithiolane 3 valeric acid

placebo pill

PLACEBO COMPARATOR
Drug: 1,2 dithiolane 3 valeric acid

Interventions

1,2 dithiolane 3 valeric acidDRUG

600 mg alpha lipoic acid per day

Alpha lipoic acid 600 mgplacebo pill

Eligibility Criteria

Age45 Years - 68 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diabetes type II, mild non proliferative diabetic retinopathy,
  • Microalbuminuria \> 30 mg/L

You may not qualify if:

  • severe non-proliferative or proliferative diabetic retinopathy
  • Macular edema
  • Eye diseases interfering with the examinations of the fundus such as preretinal haemorrhage, cataract, vitreous haemorrhage
  • Amblyopia
  • Best corrected visual acuity (VA) over 0.5
  • Glaucoma
  • Patients with cataract surgery within a period of three months
  • Other relevant retinal diseases
  • Non-authorized interventional therapy of diabetic retinopathy (e.g. laser, kryo-coagulation, vitrectomy)
  • Chronic administration of alpha lipoic acid or of more than five successive days during the last twelve months
  • Known intolerance/hypersensitivity to alpha lipoic acid
  • Type I diabetes mellitus
  • Poor metabolic control with HbA1c \>10.5 %/dl
  • Late sequelae of diabetes with organic manifestation (e.g. dialysis in cases of renal insufficiency, history of kidney transplantation, creatinine \> 1.6 mg/dl)
  • Poorly controlled arterial hypertension (systolic blood pressure \> 160 mmHg and/or diastolic blood pressure \> 95 mmHg)
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Ophthalmology

Munich, Germany, 80336, Germany

Location

MeSH Terms

Conditions

Diabetes MellitusMacular Edema

Condition Hierarchy (Ancestors)

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

Study Officials

  • Michael W Ulbig, MD

    Ludwig-Maximilians - University of Munich

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 23, 2010

First Posted

September 24, 2010

Study Start

July 1, 2000

Primary Completion

April 1, 2005

Study Completion

December 1, 2005

Last Updated

September 24, 2010

Record last verified: 2010-09

Locations

DE(1)