NCT03345667

Brief Summary

Assessment of color vision in diabetic patients before and after the use of anti-vegf in the treatment of diabetic macular edema

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2017

Shorter than P25 for all trials

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

August 1, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2017

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

November 7, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 17, 2017

Completed
Last Updated

November 17, 2017

Status Verified

November 1, 2017

Enrollment Period

2 months

First QC Date

November 7, 2017

Last Update Submit

November 16, 2017

Conditions

Retinopathy, Diabetic

Outcome Measures

Primary Outcomes (1)

  • Assessment of color vision in diabetic patients before and after the use of anti-vegf in the treatment of diabetic macular edema

    Using the Ishihara's test to analise the possible loss of vision

    3 months

Secondary Outcomes (1)

  • Frame between the injections

    1 months

Study Arms (1)

Anti-Vegf

Use intravitreous anti-vegf

Drug: lucentis

Interventions

lucentisDRUG

Use of lucentis and other anti-vegf in patients with diabetic retinopathy

Anti-Vegf

Eligibility Criteria

Age1 Year - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Assessment of color vision in diabetic patients before and after the use of anti-vegf in the treatment of diabetic macular edema. Using the Ishirara's test to evaluate the possible visual loss.

You may qualify if:

  • Having diabetic retinopathy with macular edema

You may not qualify if:

  • Not having diabetic retinopathy with macular edema

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto de Olhos de Goiania

Goiânia, Goiás, 74110120, Brazil

Location

MeSH Terms

Conditions

Diabetic Retinopathy

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 7, 2017

First Posted

November 17, 2017

Study Start

August 1, 2017

Primary Completion

October 1, 2017

Study Completion

October 30, 2017

Last Updated

November 17, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)