IRaHi: Panretinal Photocoagulation (PRP) Plus Ranibizumab for Proliferative Diabetic Retinopathy

• Sponsor: University of Sao Paulo (Other)
• Overall Status: Completed
• CT.gov ID: NCT01102946
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Duration (Months): 24
• Patients Per Site Per Month: 1.7

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Diabetic Retinopathy; Retinal Neovascularization	Drug: Ranibizumab; Procedure: Panretinal Photocoagulation	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• Official Title: Panretinal Photocoagulation Versus Panretinal Photocoagulation Plus Intravitreous Ranibizumab for High Risk Proliferative Diabetic Retinopathy
• Study Start Date: Feb 1, 2009
• Actual Primary Completion Date: Feb 1, 2011
• Actual Study Completion Date: Feb 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: PRP plus ranibizumab Patients will be submitted to panretinal photocoagulation plus intravitreal injections of ranibizumab	Drug: Ranibizumab; Ranibizumab (Lucentis), intravitreal injections of 0.05ml; Other Names: Lucentis ; Procedure: Panretinal Photocoagulation; Panretinal photocoagulation with green laser according to ETDRS
Active Comparator: PRP Patients will only be submitted to panretinal photocoagulation	Procedure: Panretinal Photocoagulation; Panretinal photocoagulation with green laser according to ETDRS

Outcome Measures

Primary Outcome Measures

1. Fluorescein leakage area (mm2) [Week 48 after inclusion in the study]

   Neovascularization area measured during fluorescein agiography middle phase

Secondary Outcome Measures

1. CMT [Week 48 after inclusion in the study]

   Macular thickness measured with Stratus OCT protocols

2. LogMAR BCVA [Week 48 after inclusion in the study]

   LogMAR best corrected visual acuity measured with ETDRS charts

3. Retina mid periphery visual field sensitivity change [Week 48 after inclusion in the study]

4. Rod pathway integrity and oscillatory potential amplitudes [Week 48 after inclusion in the study]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of São Paulo	Ribeirao Preto	Sao Paulo	Brazil	14048-900

Sponsors and Collaborators

• University of Sao Paulo

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• article on Pubmed

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01102946
• Other Study ID Numbers: IRaHi
• First Posted: Apr 13, 2010
• Last Update Posted: Aug 4, 2011
• Last Verified: Jan 1, 2011

• Keywords provided by , ,: proliferative diabetic retinopathy; retinal neovascularization; Angiogenesis Inhibitors; ranibizumab; laser
• Additional relevant MeSH terms: Retinal Diseases; Diabetic Retinopathy; Retinal Neovascularization; Neovascularization, Pathologic; Ranibizumab

Study Results

No Results Posted as of Aug 4, 2011