Intravitreal Ranibizumab Combined With Panretinal Photocoagulation in Patients With Proliferative Diabetic Retinopathy
NCT ID: NCT01746563
Last Updated: 2012-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
30 participants
INTERVENTIONAL
2011-05-31
2012-08-31
Brief Summary
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Detailed Description
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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
Conditions
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Keywords
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
SINGLE
Study Groups
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Ranibizumab
Ranibizumab 0,05 mg intravitreal injection
Ranibizumab
Intravitreal injection
Laser therapy
Laser therapy
Laser Therapy
Laser Therapy alone
Laser therapy
Laser therapy
Interventions
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Ranibizumab
Intravitreal injection
Laser therapy
Laser therapy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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University of Sao Paulo
OTHER
Responsible Party
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Daniel Araujo Ferraz
Ophthalmologist
Principal Investigators
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Walter Y Takahashi, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Sao Paulo
Locations
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Universidade of Sao Paulo
São Paulo, São Paulo, Brazil
Countries
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References
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Rentiya ZS, Ferraz DA, Hutnik R, Bae J, Machado CG, Mucciolli C, Motta AALD, Ribeiro LZ, Guan Z, Preti RC, Takahashi WY. Evaluation of contrast sensitivity in non-high-risk proliferative diabetic retinopathy treated with panretinal photocoagulation with and without intravitreal injections of ranibizumab. Arq Bras Oftalmol. 2022 Jan-Feb;85(1):37-45. doi: 10.5935/0004-2749.20220006.
Ferraz DA, Vasquez LM, Preti RC, Motta A, Sophie R, Bittencourt MG, Sepah YJ, Monteiro ML, Nguyen QD, Takahashi WY. A randomized controlled trial of panretinal photocoagulation with and without intravitreal ranibizumab in treatment-naive eyes with non-high-risk proliferative diabetic retinopathy. Retina. 2015 Feb;35(2):280-7. doi: 10.1097/IAE.0000000000000363.
Other Identifiers
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USP-RBZ2012
Identifier Type: -
Identifier Source: org_study_id