Intravitreal Aflibercept Injection or Early Vitrectomy for Diabetic Vitreous Hemorrhage

NCT04153253 | Completed Phase 4

• 1 other identifier: 003-19
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Diabetic Vitreous Hemorrhage

Keywords

Aflibercept; panretinal photocoagulation; vitrectomy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Rate of recurrent bleeding.

  9 months follow up.

• Number of additional treatment procedures .

  9 months follow up

Study Arms (2)

Group I

ACTIVE COMPARATOR

Intravitreal injection of Aflibercept followed by panretinal photocoagulation.

Drug: Aflibercept Injection [Eylea]

Group II: Early vitrectomy.

ACTIVE COMPARATOR

Early vitrectomy.

Procedure: Vitrectomy

Interventions

Aflibercept Injection [Eylea] DRUG

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.

Group I

Vitrectomy PROCEDURE

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.

Group II: Early vitrectomy.

Eligibility Criteria

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

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Al Hadi Hospital: lead

Study Sites (1)

Alhadi Hospital

Hawalli, Aljabyria, 123, Kuwait

Location

Related Publications (1)

• 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.

  PMID: 32252674 DERIVED

MeSH Terms

Interventions

aflibercept; Vitrectomy

Intervention Hierarchy (Ancestors)

Ophthalmologic Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Ahmed H Abdelhamid, MD

  Alhadi hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Abeer Mohamed Sadeck Khattab ,associate professor of ophthalmology.

Study Record Dates

• First Submitted: November 4, 2019
• First Posted: November 6, 2019
• Study Start: March 7, 2018
• Primary Completion: July 22, 2019
• Study Completion: September 29, 2019
• Last Updated: January 14, 2020

Record last verified: 2020-01

Locations

KU (1)