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Intravitreal Aflibercept Injection or Early Vitrectomy for Diabetic Vitreous Hemorrhage

Primary Purpose

Diabetic Vitreous Hemorrhage

Status
Completed
Phase
Phase 4
Locations
Kuwait
Study Type
Interventional
Intervention
Aflibercept Injection [Eylea]
Vitrectomy
Sponsored by
Al Hadi Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Vitreous Hemorrhage focused on measuring Aflibercept, panretinal photocoagulation, vitrectomy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age above 18 years.
  • Any sex.
  • Type Ι or ΙΙ DM,
  • recent diabetic VH which is causing vision impairment, precluding complete PRP and needing treatment.
  • BCVA is less than 20/70 (log MAR BCVA 0.6) and better than 20/1000 (log MAR BCVA 1.7).

Exclusion Criteria:

  • Tractional retinal detachment.
  • Previous PRP.
  • History of anti VEGF therapy within the past two months.
  • Neovascular glaucoma
  • Subhyaloid hemorrhage.
  • Vitreomacular traction.
  • Diabetic macular edema .
  • Patients with systemic contraindications for anti VEGF or unstable medical conditions as uncontrolled hypertension (persistently above 180/110 mmhg) or recent thromboembolic event within the past six months.

Sites / Locations

  • Alhadi Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group I

Group II: Early vitrectomy.

Arm Description

Intravitreal injection of Aflibercept followed by panretinal photocoagulation.

Early vitrectomy.

Outcomes

Primary Outcome Measures

Mean best corrected visual acuity(BCVA) change in both groups.
Final BCVA change measured in log MAR compared to initial BCVA.

Secondary Outcome Measures

Rate of recurrent bleeding.
Rate of recurrent vitreous hemorrhage in both groups after initial clearance.
Number of additional treatment procedures .
Additional treatment procedures done in cases of recurrent hemorrhage in both groups.

Full Information

First Posted
November 4, 2019
Last Updated
January 10, 2020
Sponsor
Al Hadi Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04153253
Brief Title
Intravitreal Aflibercept Injection or Early Vitrectomy for Diabetic Vitreous Hemorrhage
Official Title
Intravitreal Aflibercept Injection With Panretinal Photocoagulation Versus Early Vitrectomy for Diabetic Vitreous Hemorrhage
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
March 7, 2018 (Actual)
Primary Completion Date
July 22, 2019 (Actual)
Study Completion Date
September 29, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Al Hadi Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Prospective study comparing efficacy and safety of intravitreal aflibercept injection and panretinal photocoagulation to early vitrectomy for patients with diabetic vitreous hemorrhage.
Detailed Description
Selected patients were divided into two groups, Group I for whom intravitreal aflibercept injection followed by panretinal photocoagulation was done and group II for whom early vitrectomy was done.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Vitreous Hemorrhage
Keywords
Aflibercept, panretinal photocoagulation, vitrectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group I
Arm Type
Active Comparator
Arm Description
Intravitreal injection of Aflibercept followed by panretinal photocoagulation.
Arm Title
Group II: Early vitrectomy.
Arm Type
Active Comparator
Arm Description
Early vitrectomy.
Intervention Type
Drug
Intervention Name(s)
Aflibercept Injection [Eylea]
Intervention Description
Three monthly based intravitreal injections were given followed by PRP if the hemorrhage was sufficiently cleared.Intravitreal injection was done in sterile operating room, after sterilization and toweling with application of sterile speculum, Betadine 5% drops was instilled into the conjunctiva and kept for two minutes followed by wash with balanced salt solution. Injection of 2mg /0.05m aflibercept was given 4 mm from the limbus in phakic eyes and 3.5 mm in pseudophakic with compression by sterile cotton tip on the site of injection, Paracentesis was done in cases of very high IOP following injection. At the end of procedure check of visual acuity was done (to be at least light perception). PRP was done if the hemorrhage is sufficiently cleared after the third injection.
Intervention Type
Procedure
Intervention Name(s)
Vitrectomy
Intervention Description
Was done under local peribulbar anesthesia. After sterilization and toweling, wash with diluted betadine 5% was done. Insertion of three 23 valved cannulas beginning with the lower temporal one for infusion, clearance of anterior vitreous was done followed by core vitrectomy, peripheral vitrectomy , removal of posterior hyaloid aided by triamcinolone staining , trimming and removal of any vascular epicenters followed by vitreous base shaving with 360 scleral indentation, endolaser treatment was done for all eyes followed by fluid air exchange, 20% SF6 was used only if there is active significant bleeding during surgery or if there is intraoperative retinal tears, removal of cannulas was done at the end of surgery. All eyes received combination of topical steroid and antibiotic eye drops as postoperative treatment.
Primary Outcome Measure Information:
Title
Mean best corrected visual acuity(BCVA) change in both groups.
Description
Final BCVA change measured in log MAR compared to initial BCVA.
Time Frame
9 months follow up.
Secondary Outcome Measure Information:
Title
Rate of recurrent bleeding.
Description
Rate of recurrent vitreous hemorrhage in both groups after initial clearance.
Time Frame
9 months follow up.
Title
Number of additional treatment procedures .
Description
Additional treatment procedures done in cases of recurrent hemorrhage in both groups.
Time Frame
9 months follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age above 18 years. Any sex. Type Ι or ΙΙ DM, recent diabetic VH which is causing vision impairment, precluding complete PRP and needing treatment. BCVA is less than 20/70 (log MAR BCVA 0.6) and better than 20/1000 (log MAR BCVA 1.7). Exclusion Criteria: Tractional retinal detachment. Previous PRP. History of anti VEGF therapy within the past two months. Neovascular glaucoma Subhyaloid hemorrhage. Vitreomacular traction. Diabetic macular edema . Patients with systemic contraindications for anti VEGF or unstable medical conditions as uncontrolled hypertension (persistently above 180/110 mmhg) or recent thromboembolic event within the past six months.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed H Abdelhamid, MD
Organizational Affiliation
Alhadi hospital
Official's Role
Study Director
Facility Information:
Facility Name
Alhadi Hospital
City
Ḩawallī
State/Province
Aljabyria
ZIP/Postal Code
123
Country
Kuwait

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
The data will be given from the author upon request.
Citations:
PubMed Identifier
32252674
Citation
Abd Elhamid AH, Mohamed AAEA, Khattab AM. Intravitreal Aflibercept injection with Panretinal photocoagulation versus early Vitrectomy for diabetic vitreous hemorrhage: randomized clinical trial. BMC Ophthalmol. 2020 Apr 6;20(1):130. doi: 10.1186/s12886-020-01401-4.
Results Reference
derived

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Intravitreal Aflibercept Injection or Early Vitrectomy for Diabetic Vitreous Hemorrhage

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