Pre-Operative Intravitreal Bevacizumab for Tractional Retinal Detachment Secondary to Proliferative Diabetic Retinopathy

NCT01976923 | Completed Phase 3

• 1 other identifier: 1338-P
• Study Type: interventional
• Target: 224
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this is study is to assess the efficacy of pre-operative intravitreal bevacizumab (IVB) (Genentech, South San Francisco CA) in improving visual acuity, reducing operative time, complications, intra-operative and post-operative hemorrhage following small gauge pars plana vitrectomy (PPV) (23-gauge, 25-gauge or 27-gauge ) compared to small gauge PPV (23-gauge, 25-gauge or 27-gauge) alone in eyes with tractional retinal detachment (TRD) secondary to proliferative diabetic retinopathy (PDR). Hypothesis: Preoperative IVB may be beneficial for membrane dissection in diabetic tractional retinal detachment with minimally invasive vitreoretinal surgery (23-gauge transconjunctival sutureless vitrectomy \[TSV\]). In addition, post-operative rebleeding may be decreased.

Conditions

Tractional Retinal Detachment Secondary to Proliferative Diabetic Retinopathy

Keywords

Intravitreal Bevacizumab; Tractional Retinal Detachment; Proliferative Diabetic Retinopathy; Small gauge pars plana vitrectomy; Intraoperative bleeding; Post-operative vitreous hemorrhage; Visual acuity

Outcome Measures

Primary Outcomes (4)

• Intraoperative bleeding

  12 months

• Total surgical time

  12 months

• Post-operative vitreous hemorrhage

  Early (\<1 month) and late (≥ 1 month) post-operative vitreous hemorrhage (VH) (Yes or No)

  12 months

• Visual acuity change

  Mean change in best-corrected visual acuity (BCVA) at 12 months

  12 months

Secondary Outcomes (4)

• Number of endodiathermy applications

  12 months

• Intraoperative breaks

  12 months

• Change in central macular thickness

  12 months

• Proportion of eyes gaining at least 15 letters of BCVA

  12 months

Other Outcomes (1)

• Molecules in the vitreous humor and epiretinal membranes

  12 months

Study Arms (2)

Study arm

ACTIVE COMPARATOR

Intravitreal bevacizumab Small-gauge pars plana vitrectomy

Drug: Intravitreal bevacizumab; Procedure: Small-gauge pars plana vitrectomy

Control arm

SHAM COMPARATOR

Small-gauge pars plana vitrectomy

Procedure: Small-gauge pars plana vitrectomy

Interventions

Intravitreal bevacizumab DRUG

A sterile lid speculum is used to separate the lids. A subconjunctival injection of 1% lidocaine is applied to the inferotemporal quadrant. A 5% povidone iodine solution is used to disinfect the entire conjunctival surface. 1.25 mg / 0.05 mL of bevacizumab is injected using a 30-gauge needle inserted through the inferotemporal pars plana 3.5 mm from the limbus.

Study arm

Small-gauge pars plana vitrectomy PROCEDURE

Control arm; Study arm

Eligibility Criteria

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

You may qualify if:

• Age \>= 18 years with proliferative diabetic retinopathy (PDR) and tractional retinal detachment (TRD) threatening or involving the fovea.
• Diagnosis of diabetes mellitus (type 1 or type 2)
• At least one eye meets the study eye criteria
• One eye per patient will be included
• Able and willing to provide informed consent prior to any study-related procedures
• Best corrected visual acuity 20/40 or less
• Willing and able to comply with clinic visits and study-related procedures
• U.S. patients will be required to have a Health Insurance Portability and Accountability Act (HIPAA) authorization; in other countries, as applicable according to national laws

You may not qualify if:

• TRD is considered to be due to a cause other than diabetes.
• An ocular condition is present such that, in the opinion of the investigator, visual acuity loss would not improve from resolution of TRD (e.g., foveal atrophy, pigment abnormalities, dense subfoveal hard exudates, nonretinal condition, optic atrophy).
• An ocular condition is present (other than diabetes) that, in the opinion of the investigator, might affect retinal status or alter visual acuity during the course of the study (e.g., retinal vein occlusion, uveitis or other ocular inflammatory disease, glaucoma, etc.)
• History of treatment for diabetic macular edema or diabetic retinopathy at any time in the past 4 months with anti-vascular endothelial growth factor (VEGF) drugs.
• History of major ocular surgery (including vitrectomy, cataract extraction, scleral buckle, any intraocular surgery, etc.) within prior 4 months of randomization.
• History of neodymium-doped yttrium aluminium garnet (YAG) capsulotomy performed within 2 months prior to randomization.
• Intraocular pressure \>= 25 mmHg.
• Exam evidence of external ocular infection, including conjunctivitis, chalazion, or significant blepharitis
• An ocular condition is present (other than diabetes) that, in the opinion of the investigator, might affect retinal status or including hypertension, cardiovascular disease, and glycemic control.
• Significant renal disease, defined as a history of chronic renal failure requiring dialysis or kidney transplant.
• A condition that, in the opinion of the investigator, would preclude participation in the study (e.g., unstable medical status including hypertension, cardiovascular disease, and glycemic control).
• Participation in an investigational trial within 30 days of randomization that involved treatment with any drug that has not received regulatory approval at the time of study entry.
• Known allergy to any component of the study drug.
• Blood pressure \> 180/110 mmHg (systolic above 180 or diastolic above 110).
• Major surgery within 28 days prior to randomization or major surgery planned during the next 6 months.

Sponsors & Collaborators

• J. Fernando Arevalo, MD FACS: lead
• Pan American Collaborative Retina Study Group: collaborator

Study Sites (1)

King Khaled Eye Specialist Hospital

Riyadh, 11462, Saudi Arabia

Location

Related Publications (4)

• Arevalo JF, Sanchez JG, Saldarriaga L, Berrocal MH, Fromow-Guerra J, Morales-Canton V, Wu L, Maia M, Saravia MJ, Bareno J; Pan American Collaborative Retina Study Group. Retinal detachment after bevacizumab. Ophthalmology. 2011 Nov;118(11):2304.e3-7. doi: 10.1016/j.ophtha.2011.05.015. No abstract available.

  PMID: 22047908 BACKGROUND

• Arevalo JF, Sanchez JG, Lasave AF, Wu L, Maia M, Bonafonte S, Brito M, Alezzandrini AA, Restrepo N, Berrocal MH, Saravia M, Farah ME, Fromow-Guerra J, Morales-Canton V. Intravitreal Bevacizumab (Avastin) for Diabetic Retinopathy: The 2010 GLADAOF Lecture. J Ophthalmol. 2011;2011:584238. doi: 10.1155/2011/584238. Epub 2011 Mar 30.

  PMID: 21584260 BACKGROUND

• Arevalo JF, Garcia-Amaris RA. Intravitreal bevacizumab for diabetic retinopathy. Curr Diabetes Rev. 2009 Feb;5(1):39-46. doi: 10.2174/157339909787314121.

  PMID: 19199897 BACKGROUND

• Arevalo JF, Maia M, Flynn HW Jr, Saravia M, Avery RL, Wu L, Eid Farah M, Pieramici DJ, Berrocal MH, Sanchez JG. Tractional retinal detachment following intravitreal bevacizumab (Avastin) in patients with severe proliferative diabetic retinopathy. Br J Ophthalmol. 2008 Feb;92(2):213-6. doi: 10.1136/bjo.2007.127142. Epub 2007 Oct 26.

  PMID: 17965108 BACKGROUND

MeSH Terms

Conditions

Blood Loss, Surgical

Condition Hierarchy (Ancestors)

Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intraoperative Complications

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief of Vitreoretina Division

Study Record Dates

• First Submitted: October 25, 2013
• First Posted: November 6, 2013
• Study Start: November 1, 2013
• Primary Completion: July 1, 2018
• Study Completion: October 1, 2018
• Last Updated: October 9, 2018

Record last verified: 2018-10

Locations

SA (1)