Effect of Topical Nepafenac in Macular Thickening Related to Pan-Retinal Photocoagulation (NEPAF)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2008 by Asociación para Evitar la Ceguera en México.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Asociación para Evitar la Ceguera en México
ClinicalTrials.gov Identifier:
NCT00801905
First received: December 3, 2008
Last updated: NA
Last verified: December 2008
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Macular Thickening
Macular Edema
Drug: Nepafenac
Other: Lubricant
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Effect of Topical Nepafenac in Macular Thickening Related to Pan-Retinal Photocoagulation

Resource links provided by NLM:


Further study details as provided by Asociación para Evitar la Ceguera en México:

Primary Outcome Measures:
  • Central macular thickening [ Time Frame: 2 weeks after each laser session and 1 and 2 months after last laser session ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Best corrected visual acuity [ Time Frame: 2 weeks after each laser session, 1, 2 and 3 months after pan-retinal photocoagulation is completed ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 50
Study Start Date: August 2008
Estimated Study Completion Date: March 2009
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1: Nepafenac
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
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.
Other Name: Nevanac 0.1%
Placebo Comparator: 2: placebo
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
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 Name: Systane

Detailed Description:

Objective: To evaluate the effect of topical nepafenac 0.1 %, in preventing and in treating macular thickening related to pan-retinal photocoagulation in diabetic patients. Material and methods: This is a prospective, longitudinal, and controlled study in patients with diabetic retinopathy (severe non-proliferative and proliferative retinopathy), with a symmetric severity in both eyes and without a clinical significant macular edema. The best corrected visual acuity (BCVA) in all patients was 20/80 or better. All patients will undergo pan-retinal photocoagulation in three different sessions (with 2 weeks in apart between them). Each patient will receive topical nepafenac 0.1% (qid) on one eye, and placebo (qid) at the fellow eye, starting 1 week before the first retinal photocoagulation session and continued for 9 weeks ( ending 4 weeks after pan-retinal photocoagulation is completed). Spectral domain OCT and BCVA in ETDRS scale will be performed before and at 2 weeks after each laser session, and at 1, 2 and 3 months after treatment completed. BCVA and OCT outcomes of each studied period will be compared on both eyes, and side effects will be recorded.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00801905

Contacts
Contact: Dulce O Rascon-Vargas, Fellow (52) 55 10841400 ext 1167 dorv_md@hotmail.com

Locations
Mexico
Asociación Para Evitar la Ceguera en México I.A.P. Recruiting
Mexico City, Mexico, 004030
Contact: Dulce O Rascon-Vargas, Fellow    (52) 55 10841400 ext 1167    dorv_md@hotmail.com   
Asociacion para Evitar la Ceguera en Mexico I.A.P. Recruiting
Mexico City, Mexico, 04030
Contact: Guadalupe Cervantes-Coste    (52) 55 10841400 ext 1167    gpecervantes@hotmail.com   
Contact: Jans Fromow-Guerra    (52) 55 10841400 ext 1167    fromow@servidor.unam.mx   
Sponsors and Collaborators
Asociación para Evitar la Ceguera en México
Investigators
Principal Investigator: Dulce O Rascon-Vargas, Fellow Asociación Para Evitar la Ceguera en México I.A.P.
Study Chair: Guadalupe Cervantes-Coste Asociación Para Evitar la Ceguera en México I.A.P.
Study Director: Jans Fromow-Guerra Asociación Para Evitar la Ceguera en México I.A.P.
  More Information

No publications provided

Responsible Party: Dulce Oliva Rascon-Vargas, Asociación Para Evitar la Ceguera en México I.A.P.
ClinicalTrials.gov Identifier: NCT00801905     History of Changes
Other Study ID Numbers: NEPAFENAC IN PRFC, NEPAFENACO
Study First Received: December 3, 2008
Last Updated: December 3, 2008
Health Authority: Mexico: Ethics Committee

Keywords provided by Asociación para Evitar la Ceguera en México:
Macular thickening
Macular edema
Pan-retinal photocoagulation
Nepafenac
Topical non-steroidal anti inflammatory agents

Additional relevant MeSH terms:
Macular Edema
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Nepafenac
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 18, 2014