Intravitreal Ranibizumab Combined With Panretinal Photocoagulation in Patients With Proliferative Diabetic Retinopathy

Cardiovascular Diseases Clinical Trial

Official title:

Intravitreal Ranibizumab Combined With Panretinal Photocoagulation in Patients With Treatment-Naive Proliferative Diabetic Retinopathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01746563
• Other study ID #: USP-RBZ2012
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: December 6, 2012
• Last updated: December 7, 2012
• Start date: May 2011
• Est. completion date: August 2012

Study information

• Verified date: December 2012
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

To evaluate the efficacy of combination therapy with ranibizumab (RBZ) and panretinal photocoagulation (PRP) versus PRP alone in patients with treatment-naive bilateral proliferative diabetic retinopathy (PDR) as measured by mean change in visual acuity (VA), mean change in central retinal thickness (CRT) as measured by time-domain optic coherence tomography (TD-OCT) and incidence of vitreous hemorrhage (VH).

Description:

Comparative efficacy of combined treatment including intravitreal injection of 0.5 mg of Lucentis (ranibizumab) and laser photocoagulation for patients with Proliferative Diabetic Retinopathy (PDR).

Objectives:

Primary objective:

The primary objective will be to evaluate the efficacy of combined treatment with ranibizumab and laser photocoagulation versus laser photocoagulation alone in patients with severe PDR by the mean change in BCVA at V7/M6 compared to baseline. The Best Visual Acuity (BCVA) measured by the Early Treatment Diabetic Retinopathy Study (EDTRS).

Secondary objectives:

To evaluate differences in Optic Coherence Tomography (OCT) retinal thickness and total macular volume of combined treatment regiment including intravitreal injection of 0,5 mg of Lucentis (ranibizumab) and laser photocoagulation for patients with PDR at visit 7 compared to the baseline assessments.

To evaluate the percentage of patients that present with vitreous hemorrhage after the beginning of the laser treatment at visit 7 compared to the baseline assessments.

Strategic goal:

The main goal of this study is to evaluate if the use of intravitreal ranibizumab in eyes submitted to Pan-Retinal Photocoagulation (PRP) due to PDR induces less macular edema and less vitreous hemorrhage and therefore leads to a better visual outcome

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Naive Proliferative diabetic retinopathy eyes.

• Best Corrected-Visual Acuity at baseline > 20/320 in the study eye

• Patients with and without diabetic macular edema

• Type II diabetic subjects as defined by the World Health Organization aged = 18 years.

• Women must be using effective contraception

• Ability to provide written informed consent.

• Indication of panretinal photocoagulation in both eyes

Exclusion Criteria:

• Vitreous hemorrhage or pre-retinal hemorrhage

• Eyes with prior scatter (panretinal) or focal/grid photocoagulation, within the previous 6 months

• Atrophy/scarring/fibrosis/ hard exudates involving the center of the macula.

• Cataract

• Any intraocular surgery within 6 months before trial enrollment

• Previous vitrectomy.

• Any of the following underlying systemic diseases:

• History or evidence of severe cardiac disease or previous thrombus-embolic event

Study Design

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Diabetic Angiopathies
• Diabetic Retinopathy
• Eye Diseases
• Retinal Diseases
• Vascular Diseases

Intervention

Drug:
• Ranibizumab
Intravitreal injection

Procedure:
• Laser therapy
Laser therapy

Locations

Country	Name	City	State
Brazil	Universidade of Sao Paulo	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	Macular Evaluation	Changes between visual acuity from baseline to month 6.	6 Months	Yes
Secondary	Structural Macular Evaluation	Change on retinal thickness between baseline and Month 6	06 months	Yes