Biomarkers of Diabetic Retinopathy Progression | NCT01607190

Studies
Biomarkers of Diabetic Retinopathy Progression

NCT01607190

Sponsor

Association for Innovation and Biomedical Research on Light and Image

Status

Completed

Last Update Posted

Jul 19, 2018Actual

Enrollment

200Actual

Phase

Not provided

Conditions

Type 2 Diabetes Mellitus
Mild Nonproliferative Diabetic Retinopathy

Interventions

Not provided

Countries

India
Portugal

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2012

Primary Completion Date

Apr 2016Actual

Completion Date

Dec 2017Actual

First Submitted Date

May 23, 2012

First Submission Date that Met QC Criteria

May 24, 2012

First Posted Date

May 30, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 18, 2018

Last Update Posted Date

Jul 19, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to validate a predictive model of diabetic retinopathy progression in patients with diabetes mellitus type 2 patients to clinically significant macular edema (CSME) needing treatment either photocoagulation or intravitreal injections (ITV) using non-invasive techniques.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Actual

Label	Type	Description	Intervention Names
Patients with diabetic retinopathy.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
CSME needing treatment either photocoagulation or ITV.		Months 0, 6, 12 and 24.

Secondary Outcomes

Measure	Description	Time Frame
Best corrected visual acuity.		Months 0, 6, 12 and 24.
Vision loss of at least 2 lines documented in ETDRS charts		Months 0, 6, 12 and 24.
Central retinal thickness

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Type 2 diabetes mellitus
Age over 35 years-old
Non-proliferative diabetic retinopathy (Levels 20 to 35, according the ETDRS criteria)
Best Corrected Visual Acuity > 20/25 on the ETDRS chart
Informed Consent

Exclusion Criteria:

Previous laser therapy
Other retinal vascular disease
Glaucoma
Recent intraocular surgery (in the last 6 months)
Inadequate ocular media and/ or pupil dilatation that do not permit good quality fundus photography (e.g. cataract)
HbA1C > 11 % at the Screening
Subject that has a condition or that is in a situation which may put him/her at significant risk, may confound the study results or may interfere significantly with his/ her participation in the study.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

35 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with type 2 diabetes mellitus and mild nonproliferative diabetic retinopathy

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
José Cunha-Vaz, MD, PhD	Association for Innovation and Biomedical Research on Light and Image	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
LV Prasad Eye Institute		Hyderabad	Andhra Pradesh	500 034	India
AIBILI- Association for Biomedical Research and Inovation on Light and Image.

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
28785768	Derived	Cunha-Vaz J, Ribeiro L, Costa M, Simo R. Diabetic Retinopathy Phenotypes of Progression to Macular Edema: Pooled Analysis From Independent Longitudinal Studies of up to 2 Years' Duration. Invest Ophthalmol Vis Sci. 2017 May 1;58(6):BIO206-BIO210. doi: 10.1167/iovs.17-21780.

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases