PASCAL Laser Versus ETDRS Laser Associated With Intravitreal Ranibizumab (IVR) Versus Only IVR for Proliferative Diabetic Retinopathy

NCT02005432 | Unknown Phase 4

• 1 other identifier: IRALA
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

Objectives: Primary objective: To evaluate the effects on retinal morphophysiology of full scatter single target panretinal photocoagulation (PRP) versus full scatter multiple target panretinal photocoagulation (both combined with intravitreous injections of ranibizumab) versus intravitreous ranibizumab (IVR) alone in patients with proliferative diabetic retinopathy (PDR). Primary outcome: The primary endpoint for this study is the mean change in the total area of active retinal neovessels, as measured by fluorescein angiography leakage area, in mm2, from baseline to week 48. Secondary objectives:

• To assess the mean changes in best corrected visual acuity (BCVA), the mean changes in central subfield foveal thickness (CSFT), the mean changes in wave B amplitude and oscillatory potentials on a full-field electroretinogram (ERG), and the mean changes on the peripheral visual field by static perimetry (30:2 strategy), from baseline to week 48.
• To assess the incidence of adverse events during the study. Strategic goal: In the era of anti-VEGF treatment for retinal neovascularization 1, 2, 3, 4 , it is time to determine what would be the best association of PRP + anti-VEGF for proliferative diabetic retinopathy (PDR), or still, if just intravitreal anti-VEGF treatment would be even better regarding morphologic (new vessels area and CSFT) and functional parameters (BCVA, ERG response and visual field).

Conditions

Proliferative Diabetic Retinopathy

Keywords

Diabetis; Retinal Neovascularization; laser treatment

Outcome Measures

Primary Outcomes (1)

• fluorescein angiography leakage area

  The primary endpoint for this study is the mean change in the total area of active retinal neovessels, as measured by fluorescein angiography leakage area, in mm2.

  from baseline to week 48.

Study Arms (3)

SS-PRP arm

ACTIVE COMPARATOR

panfotocoagulation (PRP) single shoot (ETDRS) + 0,05ml intravitreal injection anti-VEGF (ranibizumabe)

Drug: Intravitreal Ranibizumabe; Drug: panfotocoagulation (PRP) single shoot (ETDRS)

MS-PRP arm

EXPERIMENTAL

Multiple shoot panfotocoagulation (PASCAL) plus IVR

Drug: Intravitreal Ranibizumabe; Drug: panfotocoagulation (PASCAL)

IVR arm

OTHER

only IVR (intravitreal Ranibizumabe)

Drug: Intravitreal Ranibizumabe

Interventions

Intravitreal Ranibizumabe DRUG

Intravitreal injection 0,05ml Ranibizumabe

IVR arm; MS-PRP arm; SS-PRP arm

panfotocoagulation (PASCAL) DRUG

MS-PRP arm

panfotocoagulation (PRP) single shoot (ETDRS) DRUG

SS-PRP arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diabetic patients older than 18 years
• Presence of PDR (presence of retinal neovascularization, defined as active neovessels (fine retinal vessels with saccular dilatations or extremities covered with blood or associated with recurrent vitreous hemorrhage) with visual acuity better than 20/800 and with no previous laser treatment
• Giving written informed consent.

You may not qualify if:

• Presence of advanced PDR, i.e.: vitreous hemorrhage that would prevent documentation of the eye fundus or adequate retinal photocoagulation, or presence of traction retinal detachment
• Presence of ring-shaped retinal neovascularization extending along both temporal arcades and the optic disc
• Any abnormality of the vitreoretinal interface in the macular region for which the investigator would consider vitrectomy via pars plana to be necessary
• Intravitreous injection of corticosteroids or of other antiangiogenic drugs 6 months before the evaluation for entry into the study
• Inability to fixate and to conclude the automated static perimetry exam
• Cataract surgery within the last three months
• Posterior vitrectomy with scleral introflexion at any time
• Acute ocular infection
• Allerghy to fluorescein
• Medical or psychological conditions that would prevent the patient from giving informed consent and concluding the study
• Significant uncontrolled diseases which, in the opinion of the investigator, would exclude the patient from the study
• Renal failure requiring dialysis or renal transplant or renal insufficiency with creatinine levels \>2.0 mg/dl
• Untreated diabetes mellitus
• Severe (blood pressure systolic \> 160 mmHg or diastolic \> 100 mmHg) AND untreated hypertension
• Inability to comply with study or follow-up procedures.

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

Retina and Vitreous service of the University Hospital, Faculty of Medicine of Ribeirão Preto-USP (HCFMRP)

Ribeirão Preto, São Paulo, Brazil

Location

Related Publications (1)

• Barroso RMP, Messias K, Garcia DM, Cardillo JA, Scott IU, Messias A, Jorge R. ETDRS panretinal photocoagulation combined with intravitreal ranibizumab versus PASCAL panretinal photocoagulation with intravitreal ranibizumab versus intravitreal ranibizumab alone for the treatment of proliferative diabetic retinopathy. Arq Bras Oftalmol. 2020 Nov-Dec;83(6):526-534. doi: 10.5935/0004-2749.20200096.

  PMID: 33470281 DERIVED

MeSH Terms

Conditions

Retinal Neovascularization

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Neovascularization, Pathologic; Metaplasia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 3, 2013
• First Posted: December 9, 2013
• Study Start: February 1, 2012
• Primary Completion: November 1, 2014
• Last Updated: December 9, 2013

Record last verified: 2013-12

Locations

BR (1)