NCT00907114

Brief Summary

The purpose of this study is to determine the efficacy and safety of topic ketorolac in treatment for center point thickness secondary to panphotocoagulation in proliferative diabetic retinopathy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jun 2009

Longer than P75 for phase_2

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

First Submitted

Initial submission to the registry

May 19, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 22, 2009

Completed
10 days until next milestone

Study Start

First participant enrolled

June 1, 2009

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

March 20, 2015

Status Verified

March 1, 2015

Enrollment Period

5.8 years

First QC Date

May 19, 2009

Last Update Submit

March 18, 2015

Conditions

Proliferative Diabetic RetinopathyMacular Edema

Keywords

proliferative diabetic retinopathymacular edemapanphotocoagulationtopic ketorolacefficacytreatment

Outcome Measures

Primary Outcomes (1)

  • center subfield mean thickness using Stratus OCT measured in microns

    baseline, 24, 48 and 168 hours after treatment

Secondary Outcomes (2)

  • center point thickness using Stratus OCT, measured in microns

    baseline, 24, 48 and 168 hours after treatment

  • macular volume using Stratus OCT, measured in cubic millimeters

    baseline, 24, 48 and 168 hours after treatment

Study Arms (2)

Ketorolac tromethamine

ACTIVE COMPARATOR

ocular topic ketorolac used 4 times a day during a week after panphotocoagulation

Drug: Ketorolac tromethamine

Polivynilic alcohol

PLACEBO COMPARATOR

ocular lubricant drops 4 times a day during one week after panphotocoagulation

Drug: Polivynilic alcohol

Interventions

Ketorolac tromethamineDRUG

Presentation 5 mg/ml; Dosage: one drop (0.25 mg) four times a day during one week after panphotocoagulation

Also known as: Godek
Ketorolac tromethamine
Polivynilic alcoholDRUG

Presentation: alcohol polivinilico 14 mg/ml; Dosage: one drop (0.7 mg alcohol polivinilico) four times a day during one week after panphotocoagulation

Also known as: Acuafil
Polivynilic alcohol

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • type 2 diabetes
  • proliferative diabetic retinopathy
  • without macular edema
  • adequate quality 6 mm fast macular map on the day of treatment
  • visual capacity under subjective refraction before treatment
  • signed of inform consent

You may not qualify if:

  • ocular surgery in the last 4 months
  • myopia over -6.00 diopters
  • allergy to ketorolac or non-steroids antiinflammatory
  • previous selective photocoagulation
  • using non-steroids antiinflammatory or immunomodulators
  • intraocular inflammatory
  • any retinal disease different from diabetic retinopathy
  • pregnancy
  • actual corneal disease
  • inadequate quality 6 mm fast macular map after the second visit
  • inconsistency after the second visit
  • adverse event of the drug
  • remove of the inform consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Virgilio Lima Gomez

Mexico City, Mexico City, 07760, Mexico

Location

MeSH Terms

Conditions

Macular Edema

Interventions

Ketorolac TromethamineEthanol

Condition Hierarchy (Ancestors)

Macular DegenerationRetinal DegenerationRetinal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

IndomethacinIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsAlcoholsOrganic Chemicals

Study Officials

  • Virgilio Lima Gomez, MD, MSc

    Hospital Juarez de Mexico

    STUDY CHAIR

  • Dulce M Razo Blanco Hernandez, MD

    Hospital Juarez de Mexico

    PRINCIPAL INVESTIGATOR

  • Juan Asbun Bojalil, MD, PhD

    Hospital Juarez de Mexico

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

May 19, 2009

First Posted

May 22, 2009

Study Start

June 1, 2009

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

March 20, 2015

Record last verified: 2015-03

Locations

ME(1)