APP13007, 0.05% for Cataract

Phase-Based Estimates
2
Effectiveness
3
Safety
LoBue Laser and Eye Medical Center Inc, Murrieta, CA
Cataract+3 More
APP13007, 0.05% - Drug
Eligibility
18+
All Sexes
Eligible conditions
Cataract

Study Summary

This study is evaluating whether a drug may help improve vision for individuals who have had cataract surgery.

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Eligible Conditions

  • Cataract
  • Inflammation
  • Capsule Opacification
  • Ocular Inflammation and Pain After Cataract Surgery

Treatment Effectiveness

Effectiveness Estimate

2 of 3
This is better than 85% of similar trials

Study Objectives

This trial is evaluating whether APP13007, 0.05% will improve 5 primary outcomes and 5 secondary outcomes in patients with Cataract. Measurement will happen over the course of Through Postoperative Day 15.

Day 22
Efficacy as Assessed by Number of Subjects Rescued
Day 22
Safety as Assessed by Adverse Events (AEs)
Safety as Assessed by Best Corrected Visual Acuity (BCVA)
Safety as Assessed by Intraocular Pressure (IOP)
Safety as Assessed by Ocular Anatomy
Day 85
Safety as Assessed by Corneal Endothelial Cell Measurements
Through Postoperative Day 15
Efficacy as Assessed by Anterior Chamber Cell Count (ACC)
Efficacy as Assessed by Anterior Chamber Flare (ACF)
Efficacy as Assessed by Ocular Pain Grade
Through Postoperative Day15
Efficacy as Assessed by Anterior Chamber Cell (ACC) Count

Trial Safety

Safety Estimate

3 of 3
This is better than 85% of similar trials

Trial Design

2 Treatment Groups

Matching Vehicle Placebo
APP13007 0.05% BID
Placebo group

This trial requires 370 total participants across 2 different treatment groups

This trial involves 2 different treatments. APP13007, 0.05% is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 3 and have had some early promising results.

APP13007 0.05% BID
Drug
1 drop APP13007 0.05% twice daily for 14 days to study (operated) eye
Matching Vehicle Placebo
Drug
1 drop matching vehicle placebo twice daily for 14 days to study (operated) eye
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
APP13007, 0.05%
2019
Completed Phase 2
~140

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: postoperative day 1 through postoperative day 22
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly postoperative day 1 through postoperative day 22 for reporting.

Closest Location

LoBue Laser and Eye Medical Center Inc - Murrieta, CA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 4 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Patients 18 years of age or older expected to undergo unilateral uncomplicated cataract extraction via phacoemulsification and posterior chamber intraocular lens implantation in one eye.
Have a pin-hole corrected visual acuity without other correction of ≤ 1.3 logarithm of the minimum angle of resolution (logMAR) in the study eye to be operated and contralateral eye as measured using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart at Visit 1.
Willing and able to comply with study requirements and visit schedule.
Provide signed and dated informed consent.

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people get cataract a year in the United States?

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Approximately 9 million US adults over the age of 65 have cataract, and of these, it is estimated that 6.4 million will have vision-threatening cataract by age 75.

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What are the signs of cataract?

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A number of people have signs and symptoms of cataract, but they are not normally identified and investigated by their optometrist or ophthalmologist. Visual acuity may not decrease by 50% over a period of ten years, even in the severe cases. Some patients have only minor symptoms and may be reassured. The diagnosis should then be questioned by an urgent referral to a specialist. The most common signs of cataract are a gradual loss of distance vision, the appearance of a cataract in one or both eyes, with blurred vision of near objects, and with glare which can be seen with very low lights, on cloudy days, and at night, especially when reading.

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What is cataract?

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What is cataract? Cataract is a kind of lens opacity in the eye. It happens when the lens capsule starts to leak fluid and it takes several years. In the elderly it is very common. If cataract is left untreated, the lens will begin to disintegrate causing water to leak out, making it hazel coloured and gradually opaque. Cataract affects 3% of the US population.\n

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What causes cataract?

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The study was conducted using a large sample size from a single US cohort to ascertain whether there is significant association between cataract and vitreous hemorrhage. There was not. The study was limited by its retrospective nature, retrospective design and small sample size.

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Can cataract be cured?

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The best evidence supports the notion that cataract, in conjunction with glaucoma and other eye disorders, is better treated with surgery. However, many surgeons in this group are unable to agree because of conflicting evidence to the best surgical procedure. The best surgical procedure should be determined by individual ophthalmologists. Surgical procedures are not the same in every eye clinic.

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What are common treatments for cataract?

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Patient's willingness to pay the most for cataract surgery differed significantly and there were correlations with certain patient perceptions, particularly about the need for surgery and the severity of disease. The information provided by eye care professionals regarding the options of treatment also influenced the decision to proceed with surgery. More research is required to better understand the patient's decision-making process concerning treatment.

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What is the latest research for cataract?

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A review on the surgical techniques for cataract, the most recent research on different types of laser light source, implantable intraocular lens and use of drugs for corneal diseases, retinal disorders, and ocular diseases.

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Have there been other clinical trials involving app13007, 0.05%?

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This is the first large, prospective study examining the efficacy of AP13007 in phakic, open cataract. AP13007 was non-inferior to BPT with respect to the following efficacy endpoints: achieving visual acuity >6/12, achieving VA >0.6, achieving VA >0.40, and maintaining VA ≥0.70 throughout 12–36 months. The safety profile of AP13007 was very favorable, demonstrating favorable changes from baseline in ocular and general health for 2 years post-procedure.

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Who should consider clinical trials for cataract?

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Clinical trials to evaluate medicines, devices or treatment modes are worthwhile, but the number of these trials should be increased. Given the long duration of cataract, it seems prudent to have a randomised trial for cataract evaluating the timing of surgery. The main issue when planning clinical trials for cataract is to be mindful of the difficulties and high numbers of patients required.

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What is the average age someone gets cataract?

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The average age in which one would start to get a cataract is 57.1 years and the latest age in which an eye could have cataract is 72.8 years. It is difficult to get the actual patient’s age because it is a delicate and intimate matter that should be kept confidential.. The earlier an eye is diagnosed, the higher is the chances of getting to the right treatment. Therefore, patients should come in to the clinic for proper treatment of their cataract as soon as they start having trouble with their vision.

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What does app13007, 0.05% usually treat?

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The patient should be informed in advance about the treatment in order to have an overview of the risks and benefits or treatment options. All eye surgeons must be thoroughly educated about the new technology and how a patient should be prepared by a nurse. A well informed patient will be well informed on the matter. To minimize the adverse side effects a patient should be thoroughly informed of the use of a soft contact lens in the eye before the surgery. For those of you that are already using a contact lens, you can continue. However after the surgery, a patient should start using the soft contact lens immediately. If you are not, the eye should be checked for corneal abrasions immediately after the surgery and again in 2 weeks time.

Unverified Answer

Is app13007, 0.05% typically used in combination with any other treatments?

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The current study suggests that the ophthalmologist should be aware that, even when an agent is considered to have a very low or no documented safety, the combined use of the agent with a previously developed agent is often necessary to create the maximal benefit.

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