Intravitreal Aflibercept Injection or Early Vitrectomy for Diabetic Vitreous Hemorrhage

Intravitreal Aflibercept Injection With Panretinal Photocoagulation Versus Early Vitrectomy for Diabetic Vitreous Hemorrhage

Prospective study comparing efficacy and safety of intravitreal aflibercept injection and panretinal photocoagulation to early vitrectomy for patients with diabetic vitreous hemorrhage.

Study Overview

• Status: Completed
• Conditions: Diabetic Vitreous Hemorrhage
• Intervention / Treatment: Drug: Aflibercept Injection [Eylea]; Procedure: Vitrectomy

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.

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Phase 4

Contacts and Locations

Study Locations

• Kuwait
  • Aljabyria
    • Ḩawallī, Aljabyria, Kuwait, 123
      • AlHadi hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Group I; Intravitreal injection of Aflibercept followed by panretinal photocoagulation.	Drug: Aflibercept Injection [Eylea]; 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.
ACTIVE_COMPARATOR: Group II: Early vitrectomy.; Early vitrectomy.	Procedure: Vitrectomy; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean best corrected visual acuity(BCVA) change in both groups.	Final BCVA change measured in log MAR compared to initial BCVA.	9 months follow up.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of recurrent bleeding.	Rate of recurrent vitreous hemorrhage in both groups after initial clearance.	9 months follow up.
Number of additional treatment procedures .	Additional treatment procedures done in cases of recurrent hemorrhage in both groups.	9 months follow up

Collaborators and Investigators

• Sponsor: Al Hadi Hospital
• Investigators: Study Director: Ahmed H Abdelhamid, MD, AlHadi hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 7, 2018
• Primary Completion (ACTUAL): July 22, 2019
• Study Completion (ACTUAL): September 29, 2019

Study Registration Dates

• First Submitted: November 4, 2019
• First Submitted That Met QC Criteria: November 5, 2019
• First Posted (ACTUAL): November 6, 2019

Study Record Updates

• Last Update Posted (ACTUAL): January 14, 2020
• Last Update Submitted That Met QC Criteria: January 10, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: panretinal photocoagulation; Aflibercept; vitrectomy
• Additional Relevant MeSH Terms: Pathologic Processes; Eye Diseases; Eye Hemorrhage; Hemorrhage; Vitreous Hemorrhage; Physiological Effects of Drugs; Antineoplastic Agents; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Aflibercept
• Other Study ID Numbers: 003-19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The data will be given from the author upon request.

Drug and device information, study documents

• 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