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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Daniel Araujo Ferraz, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01746563
First received: December 6, 2012
Last updated: December 7, 2012
Last verified: December 2012
  Purpose

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 Intervention Phase
Diabetic Retinopathy
Retinal Diseases
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Drug: Ranibizumab
Procedure: Laser therapy
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Intravitreal Ranibizumab Combined With Panretinal Photocoagulation in Patients With Treatment-Naive Proliferative Diabetic Retinopathy

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Macular Evaluation [ Time Frame: 6 Months ] [ Designated as safety issue: Yes ]
    Changes between visual acuity from baseline to month 6.


Secondary Outcome Measures:
  • Structural Macular Evaluation [ Time Frame: 06 months ] [ Designated as safety issue: Yes ]
    Change on retinal thickness between baseline and Month 6


Enrollment: 30
Study Start Date: May 2011
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ranibizumab
Ranibizumab 0,05 mg intravitreal injection
Drug: Ranibizumab
Intravitreal injection
Other Name: Lucentis (Novartis)
Procedure: Laser therapy
Laser therapy
Active Comparator: Laser Therapy
Laser Therapy alone
Procedure: Laser therapy
Laser therapy

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01746563

Locations
Brazil
Universidade of Sao Paulo
Sao Paulo, Brazil, 05403-000
Sponsors and Collaborators
University of Sao Paulo
Investigators
Principal Investigator: Walter Y Takahashi, PhD University of Sao Paulo
  More Information

No publications provided

Responsible Party: Daniel Araujo Ferraz, Ophthalmologist, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01746563     History of Changes
Other Study ID Numbers: USP-RBZ2012
Study First Received: December 6, 2012
Last Updated: December 7, 2012
Health Authority: Brazil: Ethics Committee

Keywords provided by University of Sao Paulo:
Proliferative Diabetic Retinopathy
Ranibizumab
Panretinal Photocoagulation

Additional relevant MeSH terms:
Cardiovascular Diseases
Diabetic Angiopathies
Diabetic Retinopathy
Eye Diseases
Retinal Diseases
Vascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases

ClinicalTrials.gov processed this record on November 20, 2014