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

NCT06879301 | Not Yet Recruiting Early Phase 1

• 2 other identifiers: AENTanta university
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetic Macular Edema (DME); Retinal Vein Occlusion (RVO); Myopic Choroidal Neovascularisation

Keywords

Aflibercept 8 mg; diabetic macular edema

Outcome Measures

Primary Outcomes (1)

• Best corrected visual acuity

  improvemnt of BCVA after intravitrreal injection of eylea HD

  1 MONTH

Study Arms (1)

60 eyes of resistant diabetic macular edema

EXPERIMENTAL

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

Interventions

Intravitreal injection of aflibercept 8 mg DRUG

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

60 eyes of resistant diabetic macular edema

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.
• patients who received other lines of treatment for DME, such as laser photocoagulation, intravitreal injection of steroids
• patients known to be glaucomatous or have an IOP ≥20 mmHg were also excluded.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

faculty of medicine, Tanta University

Tanta, 1335, Egypt

Location

MeSH Terms

Conditions

Retinal Vein Occlusion

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Venous Thrombosis; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Amin Nawar, associate professor

CONTACT

+201140095692; nawar20012002@gmail.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor of ophthalmology, Tanta University,Egypt

Study Record Dates

• First Submitted: March 11, 2025
• First Posted: March 17, 2025
• Study Start: October 19, 2025
• Primary Completion: November 19, 2025
• Study Completion: December 19, 2025
• Last Updated: March 17, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)