Port Delivery System with Ranibizumab for Wet Macular Degeneration

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
Mid Atlantic Retina, Philadelphia, PA
Wet Macular Degeneration+2 More
Port Delivery System with Ranibizumab - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a drug called PDS may help treat macular degeneration.

See full description

Eligible Conditions

  • Wet Macular Degeneration
  • Neovascular Age-related Macular Degeneration

Treatment Effectiveness

Effectiveness Estimate

3 of 3
This is better than 93% of similar trials

Study Objectives

This trial is evaluating whether Port Delivery System with Ranibizumab will improve 2 primary outcomes and 21 secondary outcomes in patients with Wet Macular Degeneration. Measurement will happen over the course of Baseline up to Week 24.

Day 93
Percentage of participants with ocular AESIs during the intermediate postoperative period
Day 37
Percentage of participants with ocular AESIs during the postoperative period
Week 24
Change in corneal ECD from baseline at Week 24 in the study eye as compared with the fellow eye
Week 40
Mean change from baseline in BCVA letter score at Week 40, as assessed using the ETDRS visual acuity chart at a starting distance of 4 meters
Mean change from baseline in Best Corrected Visual Acuity (BCVA) letter score at Week 40, as assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart at a starting distance of 4 meters
Week 48
Substudy: Change in corneal endothelial cell density (ECD) from baseline at Week 48 in the study eye as compared with the fellow eye, as assessed by specular microscopy
Week 52
Mean change in center point thickness (CPT) from baseline on spectral-domain optical coherence tomography (SD-OCT) at each scheduled visit over time to Week 52
Mean change in center point thickness (CPT) on spectral-domain optical coherence tomography (SD-OCT) at each scheduled visit over time to Week 52
Percentage of participants who lose < 15, < 10, < 5, or gain ≥ 0, > 0, ≥ 5, ≥ 10, or ≥15 letters in BCVA score from baseline at each scheduled visit over time to Week 52
Percentage of participants who lose < 15, < 10, < 5, or gain ≥ 0, > 0, ≥ 5, ≥ 10, or ≥15 letters in BCVA score from enrollment at each scheduled visit over time to Week 52
Percentage of participants with BCVA score of 69 letters (approximate 20/40 Snellen equivalent) or better at each scheduled visit over time to Week 52
Month 12
Annualized rate of ranibizumab treatments during the study compared with annualized rate of intravitreal anti-VEGF treatments prior to baseline
Annualized rate of ranibizumab treatments during the study compared with annualized rate of intravitreal anti-VEGF treatments prior to screening
Week 52
Percentage of participants with and without subretinal (SRF) and/or intraretinal fluid (IRF) on SD-OCT at baseline and over study duration
Percentage of participants with and without subretinal (SRF) and/or intraretinal fluid (IRF) on SD-OCT at enrollment and over study duration
Week 48
Change in percentage of hexagonal endothelial cells
Change in the coefficient of variation (CV) of corneal endothelial cell area (standard deviation of the cell area/mean cell area) from baseline at Weeks 24 and 48 in the study eye as compared with the fellow eye
Week 48
Percentage of participants who do not require supplemental treatment with intravitreal LUCENTIS (ranibizumab injection) 0.5 mg prior to protocol-specified refill-exchanges
Week 52
Percentage of participants with adverse device effects (ADEs) in the course of the study
Percentage of participants with ocular adverse events of special interest (AESIs)
Week 52
Percentage of participants with ocular serious adverse events (SAEs)
Week 44
Percentage of participants who do not require supplemental treatment with intravitreal ranibizumab 0.5 mg prior to protocol-specified refill-exchanges
Week 52
Percentage of participants with ocular AESIs during the follow-up period

Trial Safety

Safety Estimate

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

Trial Design

2 Treatment Groups

Port Delivery System with Ranibizumab
1 of 2
SUSVIMO
1 of 2
Experimental Treatment

This trial requires 200 total participants across 2 different treatment groups

This trial involves 2 different treatments. Port Delivery System With Ranibizumab is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 4 and have been shown to be safe and effective in humans.

Port Delivery System with RanibizumabParticipants will have the implant (filled prior to implantation with approximately 20 uL of the 100-mg/mL formulation of ranibizumab [approximately 2-mg dose of ranibizumab]) surgically inserted in the study eye at the Day 1 visit following their enrollment visit. After the initial fill of the implant with ranibizumab, patients will receive implant refill-exchanges at fixed 24-week intervals.
SUSVIMOParticipants will have the implant (filled prior to implantation with approximately 20 uL of the 100-mg/mL formulation of ranibizumab [approximately 2-mg dose of ranibizumab]) surgically inserted in the study eye at the Day 1 visit following their enrollment visit. After the initial fill of the implant with ranibizumab, patients will receive implant refill-exchanges at fixed 24-week intervals.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline up to approximately 12 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly baseline up to approximately 12 months for reporting.

Closest Location

Mid Atlantic Retina - Philadelphia, PA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Ocular Inclusion Criteria
Initial diagnosis of nAMD within 6 to 18 months prior to screening
Previous treatment with at least 3 anti-VEGF injections other than ranibizumab for nAMD per standard of care within 9 months prior to Day 1 (SUSVIMO implantation); the most recent anti-VEGF injection must have occurred within 12 weeks of PDS implantation.
The last 2 anti-VEGF injections for nAMD prior to screening must be with either bevacizumab or aflibercept
Availability of historical visual acuity data and SD-OCT imaging prior to the first anti-VEGF IVT treatment for nAMD
Availability of comprehensive historical anti-VEGF injection data including anti-VEGF agent administered and date of administration from the first anti-VEGF treatment for nAMD
Demonstrated response to prior anti-VEGF intravitreal treatment since diagnosis BCVA of 34 letters (approximate 20/200 Snellen equivalent) or better, using ETDRS chart at a starting distance of 4 meters at screening and enrollment
All subtypes of nAMD lesions are permissible
nAMD lesions at the time of diagnosis must involve the macula (6 mm diameter centered at the fovea)
Sufficiently clear ocular media and adequate pupillary dilation to allow for clinical examination and analysis and grading by the central reading center of SD-OCT images

Patient Q&A Section

Can wet macular degeneration be cured?

"Wet AMD was not cured clinically by the laser photocoagulation of the macular atrophic retina. Results from a recent paper were obtained in very selected and highly selected cohorts of patients that have a very low probability of developing wet AMD. In routine clinical practice, patients with wet AMD are usually not selected for laser photocoagulation. Results from a recent paper of laser photocoagulation of early stage wet AMD are therefore not predictable." - Anonymous Online Contributor

Unverified Answer

How many people get wet macular degeneration a year in the United States?

"Around 135,000 Americans are diagnosed each year with wet macular degeneration. Approximately 65,000 of these cases are bilateral, and it is the most common cause of blindness in adults over the age of 55. wet macular degeneration is also a common cause of vision loss and is one of the major causes of visual impairment in Americans. wet macular degeneration accounts for approximately 382,000 deaths across the United States each year. There seems to be an increasing incidence of wet macular degeneration, but the cause for the surge remains unclear. wet macular degeneration is also the third leading cause of blindness in the United States." - Anonymous Online Contributor

Unverified Answer

What are the signs of wet macular degeneration?

"The main sign of wet macular degeneration is typical vision loss in central and near vision. This is often accompanied by the visual field defect and peripheral vision loss may also be seen. A swollen optic disc," - Anonymous Online Contributor

Unverified Answer

What are common treatments for wet macular degeneration?

"Photodynamic therapy (PDT) is an emerging treatment. Laser therapies are sometimes used as initial therapy for dry macular degeneration. The use of multiple or multiple-drugs therapy is common with wet macular degeneration. The use of anti-VEGFs may be beneficial. Laser treatment may be useful in very dry (age-related macular degeneration) or wet forms of macular degeneration, although the precise indications and effectiveness remain unknown. Photodynamic therapy is an emerging treatment for wet macular degeneration. Laser therapies are sometimes used as initial therapy for dry macular degeneration." - Anonymous Online Contributor

Unverified Answer

What causes wet macular degeneration?

"Although there is no significant evidence of an environmental factor associated with wet AMD, this study does suggest that a genetic predisposition to developing wet AMD is associated with an increased number of high-affinity ocular receptors for vascular endothelial growth factor." - Anonymous Online Contributor

Unverified Answer

What is wet macular degeneration?

"Wet macular degeneration (wet AMD) is a group of age-related diseases in which the macula (imaging site of the center of the eye) is damaged." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving port delivery system with ranibizumab?

"The port delivery system appears to have a potential role in improving the efficacy and safety profile of ranibizumab compared with a conventional, controlled--release formulation after 1 year of administration. Clinicaltrials." - Anonymous Online Contributor

Unverified Answer

What does port delivery system with ranibizumab usually treat?

"Ranibizumab with the Port injection system is effective and well tolerated in patients with neovascular AMD. Although not long term data are available, the results were similar to those with 1.5 mg ranibizumab administered via intravitreal injection. Port injection of ranibizumab may reduce drug-related injection-site disorders and improve compliance in this patient population." - Anonymous Online Contributor

Unverified Answer

Does port delivery system with ranibizumab improve quality of life for those with wet macular degeneration?

"Treatment with a port system containing ranibizumab is associated with a significant improvement in the best quality of life among those who require additional injection, especially those who already had a suboptimal response or had had poor visual outcomes with ranibizumab injections." - Anonymous Online Contributor

Unverified Answer

How serious can wet macular degeneration be?

"WMD has a high recovery rate in visual acuity and the majority of patients also reported a significant improvement in their quality of life. Further, the treatment is fairly well tolerated and a significant percentage of patients even reported improvement in overall health. It thus has the potential to revert the deterioration to pre-existent level, and offer a very viable treatment option to patients who wish to control their neovascularized retina. Overall these features make [wet macular degeneration](https://www.withpower.com/clinical-trials/wet-macular-degeneration) a less severe and more manageable condition compared to dry age-related macular degeneration, with the opportunity of improving the quality of life for the patient." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for wet macular degeneration?

"The benefits of wet AMD therapy must be balanced against the potential harms. The burden of wet AMD remains high: about a third of patients and one third of all AMD patients have significant visual impairment." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating wet macular degeneration?

"In 2006, one of the first therapeutic interventions for wet AMD was a new class of drugs developed for the treatment of metastatic cancer. These new treatments were the first drugs introduced to treat wet macular degeneration for which “off-label” use has been initiated. Although the success of these new drugs was found to be limited, they demonstrated that using drugs used successfully to treat metastatic cancer proved to be valuable for treating wet AMD. In addition, a number of advances in treatment were made in the last 10 years." - Anonymous Online Contributor

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