Implantable Miniature Telescope for Age-Related Macular Degeneration

(PAS-01 Trial)

Recruiting 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

770 Participants Needed

Trial Summary

What is the purpose of this trial?

The objective of the PAS-01 study is to assess the safety of the intraocular as measured by the cumulative incidence of patients who within 5 years after implantation experience persistent vision-impairing corneal edema (corneal edema leading to persistent loss of best corrected distance visual acuity \>2 lines from pre-surgery baseline level). The study will test the null hypothesis that the percentage of patients who experience persistent vision-impairing corneal edema is \>17% against the alternative that the percentage is \<17%. The null hypothesis will be rejected if the upper bound of the two-sided 95% confidence integral for the observed percentage is \<17%.

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 data supports the effectiveness of the treatment Implantable Miniature Telescope for Age-Related Macular Degeneration?

Research shows that the implantable miniature telescope can improve vision in patients with age-related macular degeneration, with studies reporting better distance and near visual acuity and improved visual functions over time. ^{1 2 3 4 5}

Is the Implantable Miniature Telescope safe for humans?

The Implantable Miniature Telescope has been studied for safety in patients with age-related macular degeneration, with long-term results showing it is generally safe for use in humans. ^{1 2 3 6 7}

How does the implantable miniature telescope treatment differ from other treatments for age-related macular degeneration?

The implantable miniature telescope is unique because it is surgically placed inside the eye to magnify images and direct light to healthy parts of the retina, improving vision for those with severe age-related macular degeneration. Unlike other treatments that may involve injections or medications, this device offers a mechanical solution to enhance vision by acting as a tiny telescope within the eye. ^{1 2 3 8 9}

Research Team

Oliver D Schein, MD

Principal Investigator

Johns Hopkins University

Eligibility Criteria

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 untreated tears in my retina.

I have had a detached retina in the past.

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

Timeline

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Medium-term results of implantable miniaturized telescopes in eyes with age-related macular degeneration. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

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

3. New Zealand 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. [2020]

4. Czech Republic pubmed.ncbi.nlm.nih.gov

[Initial experience with implantation of miniaturized intraocular telescopes in dry type age-related macular degeneration]. [2006]

5. United States pubmed.ncbi.nlm.nih.gov

Intraocular telescopic lens evaluation in patients with age-related macular degeneration. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

The Implantable Miniature Telescope for macular degeneration. [2007]

7. England pubmed.ncbi.nlm.nih.gov

The Treatment Paradigm for the Implantable Miniature Telescope. [2020]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Optical-Quality Assessment of a Miniaturized Intraocular Telescope. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Capsule Dynamics, Implantation, and Explantation of the Smaller Incision, New-Generation Implantable Miniature Telescope: a Miyake-Apple Study. [2023]