Intravitreal Faricimab in Patients With Refractory Macula... | NCT07093385

Studies
Intravitreal Faricimab in Patients With Refractory Macular Edema

NCT07093385

Sponsor

University of Baghdad

Status

Completed

Last Update Posted

Jul 30, 2025Actual

Enrollment

43Actual

Phase

Phase 2

Conditions

Age-Related Macular Degeneration

Interventions

Faricimab Injection

Countries

Iraq

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 10, 2024Actual

Primary Completion Date

Jun 1, 2025Actual

Completion Date

Jul 1, 2025Actual

First Submitted Date

Jul 12, 2025

First Submission Date that Met QC Criteria

Jul 23, 2025

First Posted Date

Jul 30, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 23, 2025

Last Update Posted Date

Jul 30, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This prospective study will include about 40 patients with resistant wet age-related macular degeneration (AMD), diabetic macular edema (DME), or retinal vein occlusion edema (RVO) edema.The inclusion criteria are that all patients must be 40 years old or older, diagnosed with active wet AMD or macular edema due to RVO or DME, and have received at least four previous monthly injections of anti-VEGF other than faricimab. All patients will be switched to receive four loading doses of intravitreal faricimab (6 mg) at 4-week intervals for four months. The response to faricimab will be assessed regarding visual acuity and central macular thickness.

Detailed Description

This prospective study will include about 40 patients with resistant wet age-related macular degeneration (AMD), diabetic macular edema (DME), or retinal vein occlusion edema (RVO) edema.

The inclusion criteria are that all patients must be 40 years old or older, diagnosed with active wet AMD or macular edema due to RVO or DME, and have received at least four previous monthly injections of anti-VEGF other than faricimab.

All patients will be switched to receive four loading doses of intravitreal faricimab (6 mg) at 4-week intervals for four months. The response to faricimab will be assessed regarding visual acuity (functionally), central macular thickness, and the presence of subretinal or intraretinal fluid (anatomically) by optical coherence tomography OCT and compared with pre-injection visual acuity and OCT.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

43Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
faricimab	Experimental	Eligible participants received monthly intravitreal injections of Faricimab (6 mg/0.05 mL) for three months (loading dose) in a sterile environment, following standard aseptic protocols. Patients observation and examination repeated after One month from the last injection to assess treatment response (BCVA, IOP and SD-OCT re-evaluation).The response to Faricimab was determined using both anatomical (CRT) and functional (BCVA) markers	Drug: Faricimab Injection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Faricimab Injection	Drug	Faricimab (6 mg/0.05 mL) for three months (loading dose) in a sterile environment,	faricimab

Measure	Description	Time Frame
central retinal thickness	optical coherence tomography angiography	one month after the last faricimab injection

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

1. Aged 45 years or older 2. DME, RVO edema, or wet-AMD diagnosed by clinical evidence and optical coherence tomography angiography (OCTA).

3. Previously treated with:
- At least six doses of Avastin in DME or RVO edema cases or 3 dose of Avastin in AMD cases in the last year.
- At least five doses of Eylea in DME or RVO edema cases or 3 dose of Eylea in AMD cases in the last year.
  
  4. Lack of significant anatomical or visual improvement (i.e., primary non-responders) 5. Willingness and ability to attend follow-up appointments and comply with treatment protocol.

Exclusion Criteria:

1. Inconsistent treatment history: missed a dose of anti-VEGF doses, or incomplete the three loading doses of Faricimab.

2. Ocular comorbidities that could confound outcomes, such as:
- Visually significant cataract as Grade 3+ or more.
- Corneal opacity.
- uveitis
- Uncontrolled glaucoma (IOP > 25 mmHg on meds) with an increase in cup/disc ratio.
- Other macular pathologies (e.g., macular hole, epiretinal membrane ERM) 3. Severe baseline vision loss (BCVA < 6/60).

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

45 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Duaa J Kadhim	University of Baghdad	Principal Investigator

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

Study Protocol
Statistical Analysis Plan (SAP)
Analytic Code

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D008268	Macular Degeneration

ID	Term
D012162	Retinal Degeneration
D012164	Retinal Diseases
D005128	Eye Diseases

ID	Term
C000723200	faricimab

Intervention Model Description

All patients enrolled in this prospective study were a sample of Iraqi patients diagnosed with resistant AMD, DME or RVO edema. These patients diagnosed as primary non-responders to Bevacizumab, Lucentis or Aflibercept.Eligible participants received monthly intravitreal injections of Faricimab (6 mg/0.05 mL) for three months (loading dose) in a sterile environment, following standard aseptic protocols. Patients observation and examination repeated after One month from the last injection to assess treatment response (BCVA, IOP and SD-OCT re-evaluation).The response to Faricimab was determined using both anatomical (CRT) and functional (BCVA) markers.