Cryoapplication Versus Anti-VEGF Before Diabetic Vitrectomy

NCT05514925 | Unknown Phase 4

• 2 other identifiers: LR18SP09 N01IORG0009738 N95
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Pars-plana vitrectomy (PPV) is the cornerstone of surgical treatment for eyes with complicated proliferative diabetic retinopathy. Anti-VEGF intravitreal injection before PPV has shown a good effect on surgical outcomes. However, many patients present with co-morbidities that contraindicate the usage of anti-VEGF in the pre-operative period. Thus, cryoapplication, an old therapeutic tool for proliferative diabetic retinopathy may be a good alternative. The investigators present herein a comparative study between peripheral retinal cryoapplication and anti-VEGF before vitrectomy for complicated proliferative diabetic retinopathy.

Conditions

Proliferative Diabetic Retinopathy; Vitreous Hemorrhage; Tractional Retinal Detachment

Keywords

Retinal cryoapplication; Anti-VEGF; Vitrectomy

Outcome Measures

Primary Outcomes (2)

• Total surgical time

  Duration of vitrectomy from the placement of the trocars until their removal

  at the end of the vitrectomy

• Intraoperative bleeding

  occurrence of intravitreal bleeding during vitrectomy

  at the end of the vitrectomy

Secondary Outcomes (2)

• Postoperative bleeding

  one month after the vitrectomy

• Visual acuity

  one month after the vitrectomy

Study Arms (2)

Preoperative Anti-VEGF Intravitreal Injection

ACTIVE COMPARATOR

Three to five days before vitrectomy, each participant received one intravitreal Bevacizumab injection (1.25 mg,0.05 ml).

Drug: Bevacizumab Injection [Avastin]

Peripheral Retinal Cryoapplication

EXPERIMENTAL

Four to six weeks before vitrectomy, each participant underwent peripheral retinal cryoapplication.

Procedure: Peripheral Retinal Cryoapplication

Interventions

Bevacizumab Injection [Avastin] DRUG

Intravitreal injection of bevacizumab (1.25 mg, 0.05 ml) in the inferior temporal quadrant of the eye, 4 mm behind the limbus in phakic eyes, and 3.5 mm in pseudophakic eyes.

Also known as: IVB

Preoperative Anti-VEGF Intravitreal Injection

Peripheral Retinal Cryoapplication PROCEDURE

In the operating room under peribulbar anesthesia, four focal conjunctival incisions are made on each quadrant between the muscles insertions. The Tenon capsule is opened with scissors to expose the sclera. Four to six cryo-applications are made per quadrant, at the edge of muscle insertion and a line behind. The exposure time is 4 to 5 seconds. 7-0 resorbable sutures are then put on each quadrant to close the conjunctiva.

Also known as: CRYO

Peripheral Retinal Cryoapplication

Eligibility Criteria

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

You may qualify if:

• Type 1 or 2 diabetes mellitus
• Vitreous or retro-hyaloidal hemorrhage and/or tractional retinal detachment threatening or involving the macula
• No or less than 1000 impacts of preoperative retinal photocoagulation and/or iris rubeosis
• Only one eye per participant

You may not qualify if:

• Negative light perception
• Previous vitrectomy
• Contraindication to anti-VEGF therapy or retinal cryoapplication
• Associated rhegmatogenous retinal detachment

Sponsors & Collaborators

• Khairallah Moncef: lead

Study Sites (1)

Fattouma Bourguiba University Hospital - Ophthalmology Department

Monastir, 5000, Tunisia

RECRUITING

Related Publications (3)

• Zhang ZH, Liu HY, Hernandez-Da Mota SE, Romano MR, Falavarjani KG, Ahmadieh H, Xu X, Liu K. Vitrectomy with or without preoperative intravitreal bevacizumab for proliferative diabetic retinopathy: a meta-analysis of randomized controlled trials. Am J Ophthalmol. 2013 Jul;156(1):106-115.e2. doi: 10.1016/j.ajo.2013.02.008.

  PMID: 23791371 BACKGROUND

• Arevalo JF, Lasave AF, Kozak I, Al Rashaed S, Al Kahtani E, Maia M, Farah ME, Cutolo C, Brito M, Osorio C, Navarro P, Wu L, Berrocal MH, Morales-Canton V, Serrano MA, Graue-Wiechers F, Sabrosa NA, Alezzandrini AA, Gallego-Pinazo R; Pan-American Collaborative Retina Study (PACORES) Group. Preoperative Bevacizumab for Tractional Retinal Detachment in Proliferative Diabetic Retinopathy: A Prospective Randomized Clinical Trial. Am J Ophthalmol. 2019 Nov;207:279-287. doi: 10.1016/j.ajo.2019.05.007. Epub 2019 May 13.

  PMID: 31095954 BACKGROUND

• Lim AS, Ang BC. Cryoapplication in diabetic retinopathy. Int Ophthalmol. 1986 May;9(2-3):139-41. doi: 10.1007/BF00159842.

  PMID: 3721714 BACKGROUND

MeSH Terms

Conditions

Vitreous Hemorrhage

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

Eye Hemorrhage; Eye Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Imen Ksiaa, Assoc. Prof.

  Fattouma Bourguiba University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Imen Ksiaa, Assoc. Prof.

CONTACT

+21694994234; khay.imen@yahoo.fr

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: August 22, 2022
• First Posted: August 25, 2022
• Study Start: November 21, 2017
• Primary Completion: November 30, 2022
• Study Completion: December 31, 2022
• Last Updated: August 31, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)