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

Sponsor

University of Sao Paulo (Other)

Overall Status

Completed

CT.gov ID

NCT01746563

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Diabetic Retinopathy Retinal Diseases Eye Diseases Diabetic Angiopathies Vascular Diseases Cardiovascular Diseases	Drug: Ranibizumab Procedure: Laser therapy	Phase 1/Phase 2

Detailed 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

Study Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

May 1, 2011

Actual Primary Completion Date :

Aug 1, 2012

Actual Study Completion Date :

Aug 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ranibizumab Ranibizumab 0,05 mg intravitreal injection	Drug: Ranibizumab Intravitreal injection Other Names: Lucentis (Novartis) Procedure: Laser therapy Laser therapy
Active Comparator: Laser Therapy Laser Therapy alone	Procedure: Laser therapy Laser therapy

Arm

Intervention/Treatment

Experimental: Ranibizumab

Ranibizumab 0,05 mg intravitreal injection

Drug: Ranibizumab

Intravitreal injection

Other Names:

Lucentis (Novartis)

Procedure: Laser therapy

Laser therapy

Active Comparator: Laser Therapy

Laser Therapy alone

Procedure: Laser therapy

Laser therapy

Outcome Measures

Primary Outcome Measures

Macular Evaluation [6 Months]
Changes between visual acuity from baseline to month 6.

Secondary Outcome Measures

Structural Macular Evaluation [06 months]
Change on retinal thickness between baseline and Month 6

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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