Implantable Miniature Telescope for Age-Related Macular Degeneration

(PAS-01 Trial)

Enrolling by invitation at 15 trial locations

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: VisionCare, Inc.

Disqualifiers: Cognitive impairment, Glaucoma, Diabetic retinopathy, Retinal detachment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the safety of an implantable miniature telescope for individuals with advanced age-related macular degeneration, a condition that severely affects vision. Researchers seek to determine if this device can improve sight without causing corneal edema, a type of swelling that can lead to vision problems. The trial seeks participants with severe to profound vision loss from this condition, a significant cataract, and demonstrated improvement when using an external telescope.

As an unphased trial, this study offers participants a unique opportunity to contribute to groundbreaking research that could enhance vision care for many.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you have a history of steroid-responsive rise in intraocular pressure or uncontrolled glaucoma, this may affect your eligibility.

What prior data suggests that this implantable miniature telescope is safe for age-related macular degeneration?

Research shows that the implantable miniature telescope is promisingly safe for people with age-related macular degeneration (AMD). Studies have found that patients using this device for up to five years have had safe experiences. Specifically, a five-year study confirmed the telescope's safety and effectiveness for those aged 65 and older. Another study reported positive safety results after six months of use.

These studies aim to ensure the device doesn't cause serious issues, such as swelling of the eye's clear front layer, which can affect vision. The findings suggest that the risk of such problems is low. Prospective participants should discuss any concerns with a healthcare professional before joining a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Implantable Miniature Telescope for age-related macular degeneration because it offers a new way to improve vision by surgically placing a tiny telescope inside the eye. Unlike current treatments like anti-VEGF injections or laser therapies, which aim to slow vision loss, this device works by magnifying images onto the healthy part of the retina, potentially improving vision. This approach could provide a new quality of life for those with severe vision loss by enhancing their ability to see faces and read, which current treatments may not effectively address.

What evidence suggests that this implantable miniature telescope is effective for age-related macular degeneration?

Research shows that the implantable miniature telescope, studied in this trial, effectively treats advanced age-related macular degeneration (AMD). Studies have found that patients experience improved vision, making reading, recognizing faces, and watching TV easier. Long-term results indicate that the telescope continues to provide vision benefits with fewer side effects even after five years. Clinical trials confirm its effectiveness, offering hope to those with severe vision loss due to AMD. By improving central vision, it enhances the quality of life for many patients. ^{3 6 7 8 9}

Who Is on the Research Team?

Oliver D Schein, MD

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

This trial is for people over 65 with severe to profound vision loss due to age-related macular degeneration, who have a cataract and can improve their sight with an external telescope. They must be able to train for the device use and not have had any eye surgery or conditions like glaucoma that could complicate results.

Inclusion Criteria

I am 65 years old or older.

I have severe eye damage involving the center of my vision.

I have a cataract that affects my vision significantly.

Exclusion Criteria

I have had a detached retina in the past.

I have untreated tears in my retina.

Narrow angle, i.e., <Schaffer grade 2

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Implantation of the intraocular miniature telescope

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

60 months

Visits at 3, 12, 24, 36, 48, and 60 months (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Implantable Miniature Telescope

Trial Overview The study evaluates the safety of an Implantable Miniature Telescope in patients with macular degeneration by checking if less than 17% develop serious corneal swelling within five years post-implantation, which would worsen their vision significantly from before the surgery.

How Is the Trial Designed?

Group I: Implantable Miniature Telescope Experimental Treatment 1 Intervention

Post approval study

Who Is Running the Clinical Trial?

VisionCare, Inc.

Lead Sponsor

Trials

10

Recruited

1,200+

Published Research Related to This Trial

In a clinical trial involving 3 patients with age-related macular degeneration, the implantable miniaturized telescope (IMT) showed improvements in both distance and near vision over 18 months.

Despite the visual improvements, the IMT did not significantly enhance the patients' ability to perform daily activities, highlighting the need for careful patient selection and informed consent before the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medium-term results of implantable miniaturized telescopes in eyes with age-related macular degeneration. Kaşkaloğlu, M., Uretmen, O., Yağci, A.[2019]

In a study of 217 patients with end-stage age-related macular degeneration, the implantable miniature telescope (IMT) showed a significant improvement in best-corrected distance visual acuity (BCDVA) over 60 months, with an average gain of 2.41 lines across all participants.

Younger patients (ages 65 to <75) experienced better visual retention and fewer adverse events compared to older patients (≥75), indicating that age may influence the safety and efficacy of the IMT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term (60-month) results for the implantable miniature telescope: efficacy and safety outcomes stratified by age in patients with end-stage age-related macular degeneration. Boyer, D., Freund, KB., Regillo, C., et al.[2020]

In a study involving 40 patients with stable dry-type age-related macular degeneration (ARMD), the implantation of a 3.0x intraocular miniaturized telescope (IMT) significantly improved both distance and near visual acuity after one year, with mean uncorrected distance visual acuity improving from 0.9 to 0.6 logMAR and near visual acuity from 0.8 to 0.4 logMAR.

While the procedure was generally well-tolerated, with the corneal endothelium showing good tolerance, there were some complications: 6 cases required explantation and 14 patients experienced adverse effects, 7 of which were persistent.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intraocular telescopic lens evaluation in patients with age-related macular degeneration. Alió, JL., Mulet, EM., José, M., et al.[2022]

A patient with neovascular age-related macular degeneration successfully managed recurrent choroidal neovascularization after receiving an implantable miniature telescope, highlighting the potential for this treatment in similar cases.

Intravitreal injections of anti-vascular endothelial growth factor can be safely administered in eyes with a telescope, using standard ocular coherence tomography for monitoring, which suggests a feasible approach for managing complications in such patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anti-vascular endothelial growth factor injection technique for recurrent exudative macular degeneration in a telescope-implanted eye. Joondeph, BC.[2015]

The SING IMT™ miniaturized telescope shows promising optical performance for improving vision in patients with age-related macular degeneration (AMD), with even optical transmission across the visible spectrum and minimal aberrations.

In vitro testing indicates that the telescope functions effectively as a diverging lens, which could enhance retinal image magnification, making it a viable treatment option for late-stage AMD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optical-Quality Assessment of a Miniaturized Intraocular Telescope. Nepita, I., Raimondi, R., Piazza, S., et al.[2023]

The Implantable Miniature Telescope has shown promising results in improving visual acuity and quality of life for patients with bilateral end-stage macular degeneration, with 89% of participants gaining two or more lines of visual acuity after 6 months.

The device was generally safe and well tolerated, although there was a reduction in endothelial cell density post-surgery, which was manageable with careful surgical techniques and comprehensive patient management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Implantable Miniature Telescope for macular degeneration. Lane, SS., Kuppermann, BD.[2007]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/26124633/

Long-term (60-month) results for the implantable miniature ... ... more vision with fewer adverse events through month 60. Keywords: end-stage age-related macular degeneration; implantable miniature telescope; low vision.

2. sciencedirect.com sciencedirect.com/science/article/pii/S2405844024171472

Smaller-incision new-generation implantable miniature ... Age-macular degeneration (AMD) is an eye condition involving a progressive accumulation of drusen on the macula and/or pigmentary abnormalities, ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/21723614/

Comparative effectiveness and cost-effectiveness of the ... Comparative effectiveness and cost-effectiveness of the implantable miniature telescope ... age-related macular degeneration (AMD). Design: A value-based medicine ...

4. brightfocus.org brightfocus.org/resource/the-implantable-miniature-telescope-for-macular-degeneration/

The Implantable Miniature Telescope for Macular ... Some patients with age-related macular degeneration (AMD) lose their central vision in both eyes. This makes it difficult to read, recognize faces, or watch ...

5. samsaravision.com samsaravision.com/patients-caregivers/clinical-trial-outcomes

Clinical Trial Outcomes The effectiveness of the telescope implant for the treatment of Late-Stage Age-Related Macular Degeneration has been demonstrated in clinical trials.

6. enhancedvision.com enhancedvision.com/low-vision-info/implantable-miniature-telescope-5-year-study-results.html?srsltid=AfmBOoqRIyjN-UqcVqafOsrvayy5xg97zjCcigJ7ih2K-dZLPlpkkRR-

Implantable Miniature Telescope – 5 Year Study Results Five year data demonstrates long term effectiveness and safety of VisionCare's telescope implant for macular degeneration in patients 65 years and older.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4476474/

Long-term (60-month) results for the implantable miniature ... ... implantable miniature telescope (IMT) in patients with bilateral, end-stage, age-related macular degeneration (AMD) ... safety outcomes ...

8. samsaravision.com samsaravision.com/press-releases/detail/73/samsara-vision-announces-positive-six-month-visual-and

Samsara Vision Announces Positive Six-Month Visual and ... Age-related macular degeneration (AMD) is a leading cause of permanent vision loss for people age 50 and older, and the number one cause of ...

9. mdpi.com mdpi.com/2077-0383/12/2/518

Three-Month Safety and Efficacy Outcomes for the Smaller- ... Age-related macular degeneration (AMD) is a neurodegenerative disease that preferentially affects the central retina, i.e., the macula, which ...