ETDRS PRP With IVR Versus Retinal Photocoagulation Targeted to Ischemic Retina With IVR for the Treatment of PDR

NCT03904056 | Completed

• 1 other identifier: 4160/2014
• Study Type: interventional
• Target: 23
• Locations: 0 countries
• Sites: N/A

Brief Summary

Purpose: To compare panretinal photocoagulation (PRP) as described in ETDRS Study combined with intravitreal injection of ranibizumab (IVR) (ETDRS-PRP group) and retinal photocoagulation targeted to ischemic retina combined with IVR (ISQ-RP group) in patients with proliferative diabetic retinopathy (PDR). Design: Randomized prospective clinical trial. Methods: Patients with PDR were assigned to receive either PRP plus IVR (20 eyes) or retinal photocoagulation targeted to ischemic areas plus IVR (20 eyes). ETDRS best-corrected visual acuity (BCVA), central subfield macular thickness (CSFT) measured by optical coherence tomography (OCT) were performed at baseline and every 4 weeks through week 48. Area of fluorescein leakage from active new vessels (FLA) was measured every 12 weeks. Full-field electroretinography (ERG) was recorded at baseline and after 3 months.

Conditions

Diabetic Retinopathy

Keywords

Diabetic Retinopathy; Macular Edema

Outcome Measures

Primary Outcomes (1)

• Fluorescein leakage area of active new vessels (FLA)

  Compare the Area of fluorescein leakage from active new vessels in both groups in mm2 measured by wide field fluorescein angiography (Optomap 200TX; Optos PLC., Dunfermline, Scotland, United Kingdom)

  48 weeks

Secondary Outcomes (4)

• Best-corrected visual acuity (BCVA)

  48 weeks

• Central subfield thickness (CSFT)

  48 weeks

• Number of Ranibizumab Intravitreal Injections

  48 weeks

• Electroretinography

  48 weeks

Study Arms (2)

ETDRS-PRP group

ACTIVE COMPARATOR

Patients with proliferative diabetic retinopathy submitted to panretinal photocoagulation (PRP) as described in ETDRS Study combined with intravitreal injection of ranibizumab (IVR) (ETDRS-PRP group) if angluofluoresceinography demonstrated the presence of actively leaking retinal neovascularization or SD-OCT demonstrated a CSFT of more than 300 µm.

Procedure: ETDRS-PRP group

ISQ-RP group

EXPERIMENTAL

Patients with proliferative diabetic retinopathy submitted to retinal photocoagulation targeted to ischemic retina combined with intravitreal injection of ranibizumab (IVR) if angluofluoresceinography demonstrated the presence of actively leaking retinal neovascularization or SD-OCT demonstrated a CSFT of more than 300 µm.

Procedure: ISQ-RP

Interventions

ISQ-RP PROCEDURE

Patients were treated with single-spot targeted retinal photocoagulation directed toward areas of retinal nonperfusion detected by fluorescein angiography. In this group, laser treatment was performed in two sessions (week 0 and 2), with a shot duration of 100 ms, but spots were placed 1/2 burn apart and power modulated in order to generate moderately white spots on the retina. Retinal photocoagulation was performed with single-spot full-scatter PRP using Purepoint green diode laser (Alcon, Fortworth, Texas) with an Ocular Mainster PRP 165 lens with a dynamic field of view of 180 degrees, and a 200 micron spot size (which produces a 392 micron spot size on the retina). Intravitreal injection of 0.5 mg (0.05 ml) ranibizumab (Lucentis®) (IVR) were performed 180 minutes after the first laser session (week 0) by a single retina specialist.

Also known as: intravitreal injection of ranibizumab (IVR)

ISQ-RP group

ETDRS-PRP group PROCEDURE

Panretinal photocoagulation (PRP) as described in ETDRS Study combined with intravitreal injection of ranibizumab

ETDRS-PRP group

Eligibility Criteria

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

You may qualify if:

• adult patients with treatment-naive PDR and a best-corrected visual acuity (BCVA) better than 20/800

You may not qualify if:

• Presence of advanced PDR, i.e., vitreous hemorrhage that would prevent documentation of the fundoscopic examination or administration of PRP, or presence of traction retinal detachment;
• presence of ring-shaped retinal neovascularization extending along both temporal arcades and the optic disc;
• an abnormality of the vitreoretinal interface in the macular region that would lead the investigator to consider the necessity of pars plana vitrectomy;
• intravitreal injection of corticosteroids or other antiangiogenic drugs during the prior 6 months;
• inability of patient to fixate and perform reliable automated static perimetry;
• cataract surgery during the prior 3 months;
• history of pars plana vitrectomy or scleral buckle;
• acute ocular infection;
• allergy to fluorescein;
• medical or psychological conditions that would prevent the patient from giving written informed consent or completing the study;
• significant uncontrolled disease that, in the opinion of the investigator, would prevent the patient from completing the study;
• participation in another clinical study during the previous 30 days.

Sponsors & Collaborators

• São Paulo State University: lead

Related Publications (1)

• Toscano L, Messias A, Messias K, de Cenco Lopes R, Ribeiro JAS, Scott IU, Jorge R. Proliferative diabetic retinopathy treated with intravitreal ranibizumab and photocoagulation directed at ischemic retinal areas-A randomized study. Doc Ophthalmol. 2021 Dec;143(3):313-322. doi: 10.1007/s10633-021-09848-6. Epub 2021 Aug 4.

  PMID: 34347216 DERIVED

MeSH Terms

Conditions

Diabetic Retinopathy; Macular Edema

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Macular Degeneration; Retinal Degeneration

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2019
• First Posted: April 4, 2019
• Study Start: January 1, 2014
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: April 4, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share