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Monoclonal Antibodies

Intravitreal Aflibercept Injection More for Age-Related Macular Degeneration (ATLAS Trial)

N/A

Waitlist Available

Led By Carl Regillo, MD

Research Sponsored by MidAtlantic Retina

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 up to 5 years

Awards & highlights

All Individual Drugs Already Approved

No Placebo-Only Group

Summary

To evaluate the visual outcome and number of injections required during an optical coherence tomography (OCT)-guided treat and extend regimen with intravitreal aflibercept for treatment of subfoveal neovascular age-related macular degeneration (NVAMD).

Eligible Conditions

Age-Related Macular Degeneration

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2010 Phase 2 trial • 221 Patients • NCT00789477

18%

Conjunctival haemorrhage

11%

Vitreous detachment

11%

Hypertension

11%

Vitreous haemorrhage

Nasopharyngitis

Oedema peripheral

Macular oedema

Oropharyngeal pain

Posterior capsule opacification

Haemoglobin decreased

Eye pain

Protein urine present

Vitreous floaters

Glycosylated haemoglobin increased

Anaemia

Headache

Retinal haemorrhage

Haematocrit decreased

Cataract

Maculopathy

Ocular hyperaemia

Postoperative ileus

Pulmonary embolism

Bronchitis

Retinal aneurysm

Retinal neovascularisation

Atrial fibrillation

Cerebrovascular accident

Deep vein thrombosis

Hypertensive emergency

Hypoglycaemia

Localised infection

Peripheral arterial occlusive disease

Pulmonary oedema

Sepsis

Sick sinus syndrome

Squamous cell carcinoma of skin

Blood glucose increased

Glucose urine present

Hypercholesterolaemia

Intraocular pressure increased

Colon cancer stage III

Gangrene

Retinal exudates

Vision blurred

Punctate keratitis

Dyspnoea

Acute myocardial infarction

Visual acuity reduced

Diabetic retinal oedema

Transitional cell carcinoma

Blood pressure increased

Nausea

100%

80%

60%

40%

20%

Study treatment Arm

Laser Photocoagulation

Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q4

Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q8

Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321)2PRN

Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321).5Q4

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Intravitreal Aflibercept Injection MoreExperimental Treatment1 Intervention

Patient receives treatment at baseline and week 4 visit. The first time extension criteria are met the follow-up interval will be increased by 4 weeks. Each time the extension criteria is met the interval will be extended by 2 weeks to a maximum of 16 weeks. If a patient is being followed at an 8 week interval but fails to meet extension criteria at a particular visit, treatment will be administered as usual and the follow up interval will be reduced to 4 weeks. If patient is being followed at 10-16 week interval but fails to meet extension criteria at a particular visit, treatment will be administered but the follow-up interval will be reduced by 2 week increments.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Aflibercept

FDA approved

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