Intravitreal Ranibizumab Combined With Panretinal Photocoagulation in

Status Completed

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).

Clinical Trial 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

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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01746563
Study type	Interventional
Source	University of Sao Paulo
Contact
Status	Completed
Phase	Phase 1/Phase 2
Start date	May 2011
Completion date	August 2012

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05650307` - CV Imaging of Metabolic Interventions
Recruiting	`NCT05654272` - Development of CIRC Technologies
Recruiting	`NCT04515303` - Digital Intervention Participation in DASH
Completed	`NCT04056208` - Pistachios Blood Sugar Control, Heart and Gut Health	Phase 2
Recruiting	`NCT04417387` - The Genetics and Vascular Health Check Study (GENVASC) Aims to Help Determine Whether Gathering Genetic Information Can Improve the Prediction of Risk of Coronary Artery Disease (CAD)
Not yet recruiting	`NCT06032572` - Evaluation of the Safety and Effectiveness of the VRS100 System in PCI (ESSENCE)	N/A
Recruiting	`NCT04514445` - The BRAVE Study- The Identification of Genetic Variants Associated With Bicuspid Aortic Valve Using a Combination of Case-control and Family-based Approaches.
Enrolling by invitation	`NCT04253054` - Chinese Multi-provincial Cohort Study-Beijing Project
Completed	`NCT03273972` - INvestigating the Lowest Threshold of Vascular bENefits From LDL Lowering With a PCSK9 InhibiTor in healthY Volunteers	N/A
Completed	`NCT03680638` - The Effect of Antioxidants on Skin Blood Flow During Local Heating	Phase 1
Recruiting	`NCT04843891` - Evaluation of PET Probe [64]Cu-Macrin in Cardiovascular Disease, Cancer and Sarcoidosis.	Phase 1
Completed	`NCT04083872` - Clinical Study to Investigate the Pharmacokinetic Profiles and Safety of Highdose CKD-385 in Healthy Volunteers(Fasting)	Phase 1
Completed	`NCT04083846` - Clinical Study to Investigate the Pharmacokinetic Profiles and Safety of High-dose CKD-385 in Healthy Volunteers(Fed)	Phase 1
Completed	`NCT03693365` - Fluid Responsiveness Tested by the Effective Pulmonary Blood Flow During a Positive End-expiratory Trial
Completed	`NCT03619148` - The Incidence of Respiratory Symptoms Associated With the Use of HFNO	N/A
Completed	`NCT03466333` - Postnatal Enalapril to Improve Cardiovascular fUnction Following Preterm Pre-eclampsia	Phase 2
Completed	`NCT04082585` - Total Health Improvement Program Research Project
Completed	`NCT05132998` - Impact of a Comprehensive Cardiac Rehabilitation Program Framework Among High Cardiovascular Risk Cancer Survivors	N/A
Completed	`NCT05067114` - Solutions for Atrial Fibrillation Edvocacy (SAFE)
Completed	`NCT04098172` - Evaluate the Performance and Safety of Comet Pressure Guidewire in the Measurement of FFR	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms