Cryoapplication Versus Anti-VEGF Before Diabetic Vitrectomy
Primary Purpose
Proliferative Diabetic Retinopathy, Vitreous Hemorrhage, Tractional Retinal Detachment
Status
Recruiting
Phase
Phase 4
Locations
Tunisia
Study Type
Interventional
Intervention
Bevacizumab Injection [Avastin]
Peripheral Retinal Cryoapplication
Sponsored by
About this trial
This is an interventional treatment trial for Proliferative Diabetic Retinopathy focused on measuring Retinal cryoapplication, Anti-VEGF, Vitrectomy
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- Negative light perception
- Previous vitrectomy
- Contraindication to anti-VEGF therapy or retinal cryoapplication
- Associated rhegmatogenous retinal detachment
Sites / Locations
- Fattouma Bourguiba University Hospital - Ophthalmology DepartmentRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Preoperative Anti-VEGF Intravitreal Injection
Peripheral Retinal Cryoapplication
Arm Description
Three to five days before vitrectomy, each participant received one intravitreal Bevacizumab injection (1.25 mg,0.05 ml).
Four to six weeks before vitrectomy, each participant underwent peripheral retinal cryoapplication.
Outcomes
Primary Outcome Measures
Total surgical time
Duration of vitrectomy from the placement of the trocars until their removal
Intraoperative bleeding
occurrence of intravitreal bleeding during vitrectomy
Secondary Outcome Measures
Postoperative bleeding
occurrence of intravitreal bleeding after vitrectomy
Visual acuity
Best corrected logMAR visual acuity
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05514925
Brief Title
Cryoapplication Versus Anti-VEGF Before Diabetic Vitrectomy
Official Title
Peripheral Retinal Cryoapplication Versus Anti-VEGF Intravitreal Injection Before Vitrectomy for Complicated Proliferative Diabetic Retinopathy
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 21, 2017 (Actual)
Primary Completion Date
November 30, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Khairallah Moncef
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Pars-plana vitrectomy (PPV) is the cornerstone of surgical treatment of complicated proliferative diabetic retinopathy allowing the removal of vitreous opacity and releasing tractions from the retina. Surgical outcomes, however, are variable depending on a large array of pre, per, and post-operative conditions.
The preoperative anti-VEGF intravitreal injection has shown a good effect on surgical outcomes in patients with vitreous hemorrhage or tractional retinal detachment.
However, a great number of patients present with co-morbidities that contraindicate the usage of anti-VEGF in the pre-operative period.
Thus, an alternative to this adjunctive therapy is worth investigating. In another hand, cryoapplication, an old therapeutic tool for proliferative diabetic retinopathy had been used in patients with non-clear ocular media with vitreous hemorrhage.
The investigators present herein a comparative study between peripheral retinal cryoapplication and anti-VEGF before vitrectomy for complicated proliferative diabetic retinopathy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Proliferative Diabetic Retinopathy, Vitreous Hemorrhage, Tractional Retinal Detachment
Keywords
Retinal cryoapplication, Anti-VEGF, Vitrectomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Preoperative Anti-VEGF Intravitreal Injection
Arm Type
Active Comparator
Arm Description
Three to five days before vitrectomy, each participant received one intravitreal Bevacizumab injection (1.25 mg,0.05 ml).
Arm Title
Peripheral Retinal Cryoapplication
Arm Type
Experimental
Arm Description
Four to six weeks before vitrectomy, each participant underwent peripheral retinal cryoapplication.
Intervention Type
Drug
Intervention Name(s)
Bevacizumab Injection [Avastin]
Other Intervention Name(s)
IVB
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Peripheral Retinal Cryoapplication
Other Intervention Name(s)
CRYO
Intervention Description
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.
Primary Outcome Measure Information:
Title
Total surgical time
Description
Duration of vitrectomy from the placement of the trocars until their removal
Time Frame
at the end of the vitrectomy
Title
Intraoperative bleeding
Description
occurrence of intravitreal bleeding during vitrectomy
Time Frame
at the end of the vitrectomy
Secondary Outcome Measure Information:
Title
Postoperative bleeding
Description
occurrence of intravitreal bleeding after vitrectomy
Time Frame
one month after the vitrectomy
Title
Visual acuity
Description
Best corrected logMAR visual acuity
Time Frame
one month after the vitrectomy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
Negative light perception
Previous vitrectomy
Contraindication to anti-VEGF therapy or retinal cryoapplication
Associated rhegmatogenous retinal detachment
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Imen Ksiaa, Assoc. Prof.
Phone
+21694994234
Email
khay.imen@yahoo.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Imen Ksiaa, Assoc. Prof.
Organizational Affiliation
Fattouma Bourguiba University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fattouma Bourguiba University Hospital - Ophthalmology Department
City
Monastir
ZIP/Postal Code
5000
Country
Tunisia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Imen Ksiaa, Assoc. Prof.
Phone
+21694994234
Email
khay.imen@yahoo.fr
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
23791371
Citation
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.
Results Reference
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PubMed Identifier
31095954
Citation
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.
Results Reference
background
PubMed Identifier
3721714
Citation
Lim AS, Ang BC. Cryoapplication in diabetic retinopathy. Int Ophthalmol. 1986 May;9(2-3):139-41. doi: 10.1007/BF00159842.
Results Reference
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Cryoapplication Versus Anti-VEGF Before Diabetic Vitrectomy
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