Effectiveness of Intravitreal Injection of Aflibercept 8 mg in Resistant Diabetic Macular Edema, Retinal Vein Occlusion and Myopic Choroidal Neovascularisation Patients

March 11, 2025 updated by: Amin El Sayed Nawar, Tanta University

Effectiveness of Intravitreal Injection of Aflibercept 8 mg in Resistant Diabetic Macular Edema and Retinal Vein Occlusion Patients

Generally, DM is caused by insufficient insulin secretion in the body; however, the other biological mechanisms remain unclear. Long-term illness in patients with DM damages various organs in the body, such as the eyes, kidneys, and heart, seriously affecting organ function. Nowadays, the quality of life of people has improved significantly, eating habits have changed, sugar intake is increasing, and the number of patients with DM is increasing. Statistics show that in 2017, the number of patients with DM worldwide reached 425 million (aged 20-79 years), which will exceed 600 million in 30 years; moreover, patients in low- and middle-income countries, such as China and India, account for 80 percent of the total DM population (1). According to the WHO, patients with DM worldwide increased to 366 million in 2011, which is expected to increase to 500 million in 2025, with more than 150 million patients experiencing ocular complications, such as diabetic retinopathy (DR) (2, 3). DR is a form of ocular microangiopathy and the most serious DM-related complication; it seriously endangers the health of patients with DM (4). DR pathogenesis includes increased endothelial cells in the eye capillaries, increased intimal thickness, damaged pericytes, microangioma, and damaged blood-retina barrier due to increased permeability of the blood vessels, microvascular obstruction, and neovascularization (NV) (5, 6). Currently, the prevalence of DR is 34.6% worldwide; however, it is higher in some developed countries, reaching 40.3% (7). The proportion of patients with type 1 and 2 DM suffering from blindness due to DR is 3.6% and 1.6%, respectively (8). DR is associated with significantly reduced living standards, huge medical costs, and increased social burden (9, 10).

Many anti-vascular endothelial growth factor (VEGF) drugs exist; however, the use of therapeutic drugs is strictly controlled. The main drugs recommended for treating DM-related visual complications are ranibizumab and aflibercept.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Study design: This prospective interventional case study will be conducted on 60 eyes of 60 patients with resistant centrally involved diabetic macular edema following at least 3 doses of anti_VEGF therapy including cases receive previous injection of ranibzumab and aflibercept 2 mg.

All procedures were carried out under the tenets of the Helsinki Declaration. Written consent was provided by all participants after discussing the procedure, alternative treatment plans, follow-up schedules, and possible benefits and risks.

Participants: This study included resistant centrally involved diabetic macular edema (DME) cases Patients with a history of intraocular surgery, coincident retinal pathology such as retinal vascular occlusion, CNV due to age-related macular degeneration, angioid streaks, trauma, and choroiditis were excluded from the study. In addition, patients who received other lines of treatment for DME, such as laser photocoagulation, intravitreal injecrion of steroids and patients known to be glaucomatous or have an IOP ≥20 mmHg were also excluded.

Furthermore, patients with other retinal pathologies, such as prior ocular inflammation, retinal degeneration, and dense media opacity, including nuclear sclerosis, and those who did not complete 1 year of follow-up were not enrolled in the present study.

A thorough ophthalmic evaluation, including a BCVA test using a Snellen chart that was converted to LogMAR for statistical analysis, IOP measurements using applanation tonometry, an anterior segment examination using a slit lamp, a posterior segment examination by slit lamp bimicroscopy using a +78 D lens, and indirect ophthalmoscopy, was performed for all patients. Spectral-domain OCT (Topcon 3D Optical Coherence Tomography) was performed for all patients at baseline and at the postoperative first-month visit and then monthly for 1 year.

Surgical procedure:

Preoperative preparation: Patients were prepared by applying topical fluoroquinolone eye drops (moxifloxacin hydrochloride 0.5% Vigamox, Alcon, USA) 4 times daily for three days before injection.

Procedure: The intravitreal injection was carried out in the operating room under complete aseptic techniques with an operating microscope. After the topical application of anaesthetic drops (benoxinate hydrochloride 0.4%, Benox, Epico, Egypt) to the ocular surface followed by the topical application of 10% povidone-iodine (Betadine) to the periocular area, lids and eye lashes, 5% povidone iodine was administered inside the conjunctival sac for three minutes before the intravitreal injection. 0.07 ml of aflibercept (8 mg) was injected into the vitreous cavity in the inferotemporal quadrant of the globe using a 30-gauge needle 4 mm from the limbus.

Postoperative care: After injection, topical antibiotic drops (moxifloxacin hydrochloride 0.5% Vigamox, Alcon, USA) were applied, and the eye was patched for several hours. Patients were instructed to administer antibiotic drops four times daily for 3 days. Patients were examined the following day and the third day after injection to exclude any complications, such as an elevated IOP, endophthalmitis, retinal breaks, retinal detachment and vitreous hemorrhage. All patients were followed up at 4-week intervals after the first injection. At each visit, a thorough ophthalmic examination and SD-OCT were performed. Pro re nata (PRN) regimen was followed in this study, in which an additional intravitreal injection will be given monthly if no improvement in or stabilization of best corrected visual acuity (improvement by more than one line in the Snellen chart) and/or persistent neurosensory detachment was detected on SD-OCT.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Tanta, Egypt, 1335
        • Faculty of medicine, Tanta University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

This study included resistant centrally involved diabetic macular edema (DME) cases

-

Exclusion Criteria:

  1. Patients with a history of intraocular surgery
  2. coincident retinal pathology such as retinal vascular occlusion, CNV due to age-related macular degeneration, angioid streaks, trauma, and choroiditis were excluded from the study.
  3. patients who received other lines of treatment for DME, such as laser photocoagulation, intravitreal injection of steroids

  4. patients known to be glaucomatous or have an IOP ≥20 mmHg were also excluded.

    -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 60 eyes of resistant diabetic macular edema

This prospective interventional case study will be conducted on 60 eyes of 60 patients with resistant centrally involved diabetic macular edema following at least 3 doses of anti_VEGF therapy including cases receive previous injection of ranibzumab and aflibercept 2 mg.

All procedures were carried out under the tenets of the Helsinki Declaration. Written consent was provided by all participants after discussing the procedure, alternative treatment plans, follow-up schedules, and possible benefits and risks.

Participants: This study included resistant centrally involved diabetic macular edema (DME) cases
Drug: Intravitreal injection of aflibercept 8 mg

Preoperative preparation: Patients were prepared by applying topical fluoroquinolone eye drops (moxifloxacin hydrochloride 0.5% Vigamox, Alcon, USA) 4 times daily for three days before injection.

Procedure: The intravitreal injection was carried out in the operating room under complete aseptic techniques with an operating microscope. After the topical application of anaesthetic drops (benoxinate hydrochloride 0.4%, Benox, Epico, Egypt) to the ocular surface followed by the topical application of 10% povidone-iodine (Betadine) to the periocular area, lids and eye lashes, 5% povidone iodine was administered inside the conjunctival sac for three minutes before the intravitreal injection. 0.07 ml of aflibercept (8 mg) was injected into the vitreous cavity in the inferotemporal quadrant of the globe using a 30-gauge needle 4 mm from the limbus.

Postoperative care: After injection, topical antibiotic drops (moxifloxacin hydrochloride 0.5% Vigamox, Alcon, USA) were applied, and the eye was

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Best corrected visual acuity
Time Frame: 1 MONTH
improvemnt of BCVA after intravitrreal injection of eylea HD
1 MONTH

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tanta University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 19, 2025

Primary Completion (Estimated)

November 19, 2025

Study Completion (Estimated)

December 19, 2025

Study Registration Dates

First Submitted

March 11, 2025

First Submitted That Met QC Criteria

March 11, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 11, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AEN
  • Tanta university (Other Identifier: Tanta University)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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