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Effect of Topical Nepafenac in Macular Thickening Related to Pan-Retinal Photocoagulation (NEPAF)
This study is currently recruiting participants.
Verified by Asociación para Evitar la Ceguera en México, December 2008
First Received: December 3, 2008   No Changes Posted
Sponsor: Asociación para Evitar la Ceguera en México
Information provided by: Asociación para Evitar la Ceguera en México
ClinicalTrials.gov Identifier: NCT00801905
  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 II

Study Type: Interventional
Study Design: Prevention, Non-Randomized, Single Blind (Subject), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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
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
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.
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
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

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
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: Asociación Para Evitar la Ceguera en México I.A.P. ( Dulce Oliva Rascon-Vargas )
Study ID Numbers: NEPAFENAC IN PRFC, NEPAFENACO
Study First Received: December 3, 2008
Last Updated: December 3, 2008
ClinicalTrials.gov Identifier: NCT00801905     History of Changes
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:
Anti-Inflammatory Agents
Eye Diseases
Physiological Effects of Drugs
Edema
Macular Degeneration
Retinal Degeneration
Pharmacologic Actions
Macular Edema
Signs and Symptoms
Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Retinal Diseases

ClinicalTrials.gov processed this record on February 08, 2010