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Monoclonal Antibodies

Patients with macular edema from RAM for Macular Edema

Phase 1
Waitlist Available
Research Sponsored by Kamal Kishore, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up six months.
Awards & highlights

Study Summary

Phase 1, non-randomized, open label, noncomparative trial to study the effect of intravitreal injection of aflibercept on eyes with symptomatic macular edema from retinal artery macroaneurysms.

Eligible Conditions
  • Macular Edema
  • Retinal Artery Macroaneurysm

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~six months
This trial's timeline: 3 weeks for screening, Varies for treatment, and six months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Safety profile as demonstrated by the incidence and severity of ocular and systemic adverse events in patients with macular edema caused by retina artery macroaneurysm(s) after intravitreal injection of 2 mg of aflibercept
Secondary outcome measures
Change in best-corrected ETDRS visual acuity at 3 and 6 months.
Change in central field macular thickness at 3 and 6 months
Number of patients requiring additional treatment beyond baseline and total number of treatments
+2 more

Side effects data

From 2020 Phase 4 trial • 20 Patients • NCT02559180
5%
Hypertension and Hyperglycemia
5%
Chest pain
5%
Bilateral lower limb cellulitis
5%
Death of unknown cause
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm

Trial Design

1Treatment groups
Experimental Treatment
Group I: Patients with macular edema from RAMExperimental Treatment1 Intervention
Intravitreal aflibercept 2.0 mg injection for eyes meeting eligibility criteria will be administered at baseline. Reinjection of the drug for protocol-defined criteria at least two months after previous injection.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Aflibercept
FDA approved

Find a Location

Who is running the clinical trial?

Kamal Kishore, MDLead Sponsor

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Intravitreal Aflibercept Injection for Symptomatic Macular Edema From Retinal Artery Macroaneurysms
Kamal Kishore, MD 2015. "Intravitreal Aflibercept Injection for Symptomatic Macular Edema From Retinal Artery Macroaneurysms". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02403128.
All > Macular Edema
~1 spots leftby May 2025
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