Treatment of Bardet-Biedl-Syndrome With Metformin for Evaluation of a Possible Visual Improvement

Visual Impairment Clinical Trial

— BBS  

Official title:

Treatment of Infantile and Juvenile Patients With Bardet-Biedl-Syndrome With Metformin. Evaluation of a Visual Improvement as a Side Effect of the Pediatric Treatment of Adipositas - a Prospective Pilot Study Without Control

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03490019
• Other study ID #: BBS V1.0
• Status: Withdrawn
• Phase: Phase 2
• Start date: April 1, 2018
• Est. completion date: August 2020

Study information

• Verified date: February 2018
• Source: University Hospital Tuebingen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In this prospective pilot study without control group children and young adults (10-25 years old) diagnosed with Bardet-Biedl syndrome and treated with Metformin for their adipositas will be evaluated for a possible additional effect of Metformin on visual acuity.

Description:

Within experiments with animals a positive effect of Metformin concerning the photo receptors was shown. Several patients of the university hospital Tübingen with Bardet-Biedl-Syndrome and Metformin therapy due to their adipositas reported a subjective improvement of the visual acuity which was confirmed by opthalmologic tests.

This will be checked in a prospective pilot study without control group including children and young adults (10-25 years old) diagnosed with Bardet-Biedl syndrome and treated with Metformin for their adipositas. Therefore a possible additional effect of Metformin on visual acuity will be evaluated under controlled conditions.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2020
• Est. primary completion date: October 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 25 Years

Eligibility

Inclusion Criteria:

• clinically confirmed Bardet-Biedl-syndrome

• Visual acuity between 0.05 and 0.8

• Age >=10 year to <25 years

• Visual field III4e or V4e with diameter >=5°, if II4e not seen

• informed consent of patient and/or legal representative

Exclusion Criteria:

• Hypoglycaemia (<50mg/dl)

• Therapy with Metformin within the last three months

• Participation in another clinical trial

• pregnancy, lactation

• any contra indication concerning Metformin therapy

• Renal failure (creatinine clearance < 60ml/min)

• any acute disorder accompanied by clouding of consciousness

• acute or chronic disorders possible accompanied by tissue hypoxia

• Liver insufficiency, alcohol abuse

• not fluent in German language

Related Conditions & MeSH terms

• Bardet-Biedl Syndrome
• Syndrome
• Vision Disorders
• Vision, Low
• Visual Impairment

Intervention

Drug:
• Metformin
500, 850 or 1000 mg depending on body weight once daily for 24 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Tuebingen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual acuity	Course of visual acuity according to appropriate table	Baseline to day 210
Secondary	Number of letters read	Course visual acuity defined as number of letters read	Baseline to day 210
Secondary	Results of Static perimetry	Course of results of static perimetry given by measurement of light contrast sensitivity within at least 5 central points.	Baseline to day 210
Secondary	Results of Kinetic perimetry	Course of results of kinetic perimetry given by mapping the visual field sensitivity boundaries using Goldmann perimetry	Baseline to day 210
Secondary	Electroretinogram (ERG) dim-flash	Course of values of ERG dim-flash	Baseline to day 210
Secondary	Electroretinogram (ERG) standard flash	Course of values of ERG standard flash at 3 ods/m2	Baseline to day 210
Secondary	Electroretinogram (ERG) cone-single-flash	Course of values of ERG cone-single-flash at 30cd/m2	Baseline to day 210
Secondary	Electroretinogram (ERG) 30-Hz-Flicker	Course of values of ERG measured by 30-Hz-Flicker in all patients	Baseline to day 210
Secondary	Visual evoked potential (VEP) - amplitude	Course of results of measurement of VEP amplitude	Baseline to day 210
Secondary	Visual evoked potential (VEP) - latency time	Course of results of measurement of VEP latency time	Baseline to day 210
Secondary	FST	Full-Field-Stimulus Threshold	Baseline to day 210
Secondary	optical coherence tomography (OCT)	Course of central thickness of retina measured by OCT	Baseline to day 210