NCT00801905

Brief Summary

The purpose of this study is to determine whether topical nepafenac (qid) is effective in preventing and treating macular thickening related pan-retinal photocoagulation in patients with diabetic retinopathy.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Aug 2008

Shorter than P25 for phase_2

Geographic Reach
1 country

2 active sites

Status
terminated

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, 2008

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

December 3, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 4, 2008

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

May 30, 2024

Status Verified

May 1, 2024

Enrollment Period

4 months

First QC Date

December 3, 2008

Last Update Submit

May 29, 2024

Conditions

Macular ThickeningMacular Edema

Keywords

Macular thickeningMacular edemaPan-retinal photocoagulationNepafenacTopical non-steroidal anti inflammatory agents

Outcome Measures

Primary Outcomes (1)

  • Central macular thickening

    2 weeks after each laser session and 1 and 2 months after last laser session

Secondary Outcomes (1)

  • Best corrected visual acuity

    2 weeks after each laser session, 1, 2 and 3 months after pan-retinal photocoagulation is completed

Study Arms (2)

1: Nepafenac

ACTIVE COMPARATOR

Topical nepafenac 0.1% is administrated every 6 hour 1 week before start pan-retinal photocoagulation and 4 weeks during all laser session performed biweekly, and 4 weeks after last laser sessión was completed.

Drug: Nepafenac

2: placebo

PLACEBO COMPARATOR

Topical lubricating is administrated every 6 hours at fellow eye 1 week before start pan-retinal photocoagulation, 4 weeks during each laser session performed biweekly, and 4 weeks after last laser sessión was completed

Other: Lubricant

Interventions

NepafenacDRUG

Topical nepafenac 0.1% is administrated every 6 hour 1 week before start pan-retinal photocoagulation and 4 weeks during all laser session performed biweekly, and 4 weeks after last laser sessión was completed.

Also known as: Nevanac 0.1%
1: Nepafenac
LubricantOTHER

Topical lubricating is administrated every 6 hours at fellow eye 1 week before start pan-retinal photocoagulation, 4 weeks during each laser session performed biweekly, and 4 weeks after last laser sessión was completed

Also known as: Systane
2: placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with Severe and proliferative Diabetic Retinopathy
  • Symmetric severity grade on both eyes
  • Best corrected visual acuity better than 20/80

You may not qualify if:

  • Clinical significant macular edema
  • Lens opacity
  • Ocular surgery 6 months or less before recruit
  • Uveitis history
  • Actual use of topical or systemic non-steroidal anti inflammatory agents
  • Actual or history of other macular diseases
  • Ocular surface diseases
  • Vitreomacular traction syndrome
  • Other vascular retinal diseases different to diabetic retinopathy
  • Actual or history of use of topical prostaglandin analogues

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Asociación Para Evitar la Ceguera en México I.A.P.

Mexico City, 004030, Mexico

Location

Asociacion para Evitar la Ceguera en Mexico I.A.P.

Mexico City, 04030, Mexico

Location

MeSH Terms

Conditions

Macular Edema

Interventions

nepafenacLubricants

Condition Hierarchy (Ancestors)

Macular DegenerationRetinal DegenerationRetinal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Specialty Uses of ChemicalsChemical Actions and Uses

Study Officials

  • Dulce O Rascon-Vargas, Fellow

    Asociación Para Evitar la Ceguera en México I.A.P.

    PRINCIPAL INVESTIGATOR

  • Guadalupe Cervantes-Coste

    Asociación Para Evitar la Ceguera en México I.A.P.

    STUDY CHAIR

  • Jans Fromow-Guerra

    Asociación Para Evitar la Ceguera en México I.A.P.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 3, 2008

First Posted

December 4, 2008

Study Start

August 1, 2008

Primary Completion

December 1, 2008

Study Completion

March 1, 2009

Last Updated

May 30, 2024

Record last verified: 2024-05

Locations

ME(2)