Panretinal Photocoagulation (PRP) Plus Ranibizumab for Proliferative Diabetic Retinopathy

Diabetic Retinopathy Clinical Trial

— IRaHi  

Official title:

Panretinal Photocoagulation Versus Panretinal Photocoagulation Plus Intravitreous Ranibizumab for High Risk Proliferative Diabetic Retinopathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01102946
• Other study ID #: IRaHi
• Status: Completed
• Phase: Phase 2
• First received: April 9, 2010
• Last updated: August 3, 2011
• Start date: February 2009
• Est. completion date: February 2011

Study information

• Verified date: January 2011
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the effects of panretinal photocoagulation plus intravitreal ranibizumab for the treatment of patients with high risk proliferative diabetic retinopathy in terms of changes in visual acuity and neovascularization area.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Age = 18 years old

• High risk proliferative diabetic retinopathy

• Visual acuity = 20/800

• No previous laser treatment for diabetic retinopathy

Exclusion Criteria:

• Previous pars plana vitrectomy

• Systemic thrombo-embolic events

• Uncontrolled systemic hypertension

• Conditions avoiding adequated documentation

• Previous eye surgery in the last 6 months before inclusion in the study

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Retinopathy
• Neovascularization, Pathologic
• Retinal Diseases
• Retinal Neovascularization

Intervention

Drug:
• Ranibizumab
Ranibizumab (Lucentis), intravitreal injections of 0.05ml

Procedure:
• Panretinal Photocoagulation
Panretinal photocoagulation with green laser according to ETDRS

Locations

Country	Name	City	State
Brazil	University of São Paulo	Ribeirao Preto	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fluorescein leakage area (mm2)	Neovascularization area measured during fluorescein agiography middle phase	Week 48 after inclusion in the study	No
Secondary	CMT	Macular thickness measured with Stratus OCT protocols	Week 48 after inclusion in the study	No
Secondary	LogMAR BCVA	LogMAR best corrected visual acuity measured with ETDRS charts	Week 48 after inclusion in the study	No
Secondary	Retina mid periphery visual field sensitivity change		Week 48 after inclusion in the study	No
Secondary	Rod pathway integrity and oscillatory potential amplitudes		Week 48 after inclusion in the study	No

External Links

•   article on Pubmed