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Alprostadil in Maculopathy Study (AIMS)

Information source: UCB Pharma
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Macular Degeneration

Intervention: Alprostadil (prostaglandin E1) (Drug); Placebo (Other)

Phase: Phase 3

Status: Terminated

Sponsored by: UCB Pharma

Official(s) and/or principal investigator(s):
UCB Clinical Trial Call Center, Study Director, Affiliation: +1 877 822 9493 (UCB)

Summary

Evaluation of efficacy of alprostadil (prostaglandin E1) for treatment of patients suffering from dry age-related macula degeneration

Clinical Details

Official title: Confirmatory, Prospective, Randomized, Double-blind, Placebo-controlled, Parallel Groups Study to Assess the Efficacy and Safety of Prostaglandin E1 in Subjects With Dry Age-related Macular Degeneration.

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Difference in Visual Acuity Between Measurements at 3 Months After Drug Intervention and Measurements at Baseline (Assessed Within Early Treatment Diabetic Retinopathy Study (ETDRS) Chart)

Secondary outcome:

The Difference in Visual Acuity Between Measurements Immediately After Intervention and Measurements at Baseline

The Difference in Visual Acuity Between Measurements at 6 Months After Intervention and Measurements at Baseline

Progression of the Dry Age-related Macular Degeneration

Development of a Wet Age-related Macular Degeneration

The Difference in Contrast Sensitivity Between Measurements Immediately After Intervention and Measurements at Baseline

The Difference in Contrast Sensitivity Between Measurements at 3 Months After Intervention and Measurements at Baseline

The Difference in Contrast Sensitivity Between Measurements at 6 Months After Intervention and Measurements at Baseline

The Difference in Color Vision Between Measurements Immediately After Intervention and Measurements at Baseline

The Difference in Color Vision Between Measurements at 3 Months After Intervention and Measurements at Baseline

The Difference in Color Vision Between Measurements at 6 Months After Intervention and Measurements at Baseline

Detailed description: Results of the planned interim analysis indicated that the number of originally planned patients were not sufficient to reach statistical significance in the primary end point. Instead of increasing the sample size accordingly, it was decided to terminate the study and plan future proceedings based on a careful analysis of the unblinded results.

Eligibility

Minimum age: 50 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Male and female subjects older than 50 years of age.

- Dry age-related macula degeneration (AMD) with hard drusen and possibly beginning

geographic atrophy in one eye

- Visual acuity between 0. 2 and 0. 7 (logMAR) assessed with ETDRS charts

Exclusion Criteria:

- Dry AMD AREDS category 3 or 4 in both eyes

- Wet AMD in at least one eye

- Detachment of the pigmentary epithelium

- Glaucoma

- Diabetic retinopathy

- Medical history of retinal vein occlusion

- Uveitis

- Cataract surgery during the study

- High myopia (< -6 dpt) with pathological findings of the retina

- Medical history of any opthalmic surgery with complications

- Medical history of cataract surgery without complications within the last 12 weeks

- Medical history of vitrectomy

- AREDS medication within the last 2 days

- Opthalmologic dietary supplements within the last 2 days

- Medical history of retinal hemorrhage

- Cardiac failure (NYHA grade II or higher)

- Inadequately controlled coronary heart disease or cardiac arrhythmia

- Subject has a medical history and/or suspicion of pulmonary edema or pulmonary

infiltration

- Subject has a peripheral edema

- Myocardial infarction within 6 months prior to enrollment

- Subject has renal insufficiency, compensated retention (creatinine > 1,5 mg/dL)

- Subject has known existing malignant disease

- Severe chronic obstructive pulmonary disease

- Subject has a venoocclusive lung disease

- Known hepatic disease

- Inadequately controlled or untreated hypertension (systolic blood pressure ≥ 180

mmHg, diastolic blood pressure ≥ 110 mmHg)

- Subject has upper grade cardiac valvular disorders

- Pregnancy or lactation period

- Known hypersensitivity to PGE1 or to any component of the trial medication

- Subject has a history of chronic alcohol or drug abuse within the past 2 years

- Subject has known lactose intolerance

- Poor general state of health or other criteria

- Subject has other serious illness

- Laboratory values outside the normal range unless considered not clinically relevant

by the investigator

Locations and Contacts

Berlin, Germany

Bochum, Germany

Dortmund, Germany

Karlsruhe, Germany

Muenchen, Germany

Muenster, Germany

Additional Information

FDA Safety Alerts and Recalls

Product Information

Starting date: July 2006
Last updated: October 17, 2014

Page last updated: August 23, 2015

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