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

December 6, 2012
December 7, 2012
May 2011
August 2012   (final data collection date for primary outcome measure)
Macular Evaluation [ Time Frame: 6 Months ] [ Designated as safety issue: Yes ]
Changes between visual acuity from baseline to month 6.
Same as current
Complete list of historical versions of study NCT01746563 on ClinicalTrials.gov Archive Site
Structural Macular Evaluation [ Time Frame: 06 months ] [ Designated as safety issue: Yes ]
Change on retinal thickness between baseline and Month 6
Same as current
Not Provided
Not Provided
 
Intravitreal Ranibizumab Combined With Panretinal Photocoagulation in Patients With Proliferative Diabetic Retinopathy
Intravitreal Ranibizumab Combined With Panretinal Photocoagulation in Patients With Treatment-Naive Proliferative Diabetic Retinopathy

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).

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

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
  • Diabetic Retinopathy
  • Retinal Diseases
  • Eye Diseases
  • Diabetic Angiopathies
  • Vascular Diseases
  • Cardiovascular Diseases
  • Drug: Ranibizumab
    Intravitreal injection
    Other Name: Lucentis (Novartis)
  • Procedure: Laser therapy
    Laser therapy
  • Experimental: Ranibizumab
    Ranibizumab 0,05 mg intravitreal injection
    Interventions:
    • Drug: Ranibizumab
    • Procedure: Laser therapy
  • Active Comparator: Laser Therapy
    Laser Therapy alone
    Intervention: Procedure: Laser therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
August 2012
August 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT01746563
USP-RBZ2012
Yes
Daniel Araujo Ferraz, University of Sao Paulo
University of Sao Paulo
Not Provided
Principal Investigator: Walter Y Takahashi, PhD University of Sao Paulo
University of Sao Paulo
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP