Clinical trial NCT01746563: Intravitreal Ranibizumab Combined With Panretinal Photocoagulation in Patients With Proliferative Diabetic Retinopathy
Official title: Intravitreal Ranibizumab Combined With Panretinal Photocoagulation in Patients With Treatment-Naive Proliferative Diabetic Retinopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Diabetic Retinopathy
Retinal Diseases
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Keywords: Proliferative Diabetic Retinopathy
Ranibizumab
Panretinal Photocoagulation
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2012-12-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

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 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

Primary outcomes:
measure: Macular Evaluation
timeFrame: 6 Months
Secondary outcomes:
measure: Structural Macular Evaluation
timeFrame: 06 months
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Universidade of Sao Paulo
Study officials:
affiliation: University of Sao Paulo
name: Walter Y Takahashi, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.