Is NCT03683251 recruiting in Beverly Hills, CA?

Yes, NCT03683251 is currently recruiting participants at its Beverly Hills, CA location. This macular degeneration clinical trial is actively enrolling qualified participants.

How do I join the macular degeneration clinical trial in Beverly Hills?

To join this clinical trial in Beverly Hills, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Beverly Hills clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Macular Degeneration Clinical Trial in Beverly Hills, CA

About This Macular Degeneration Study in Beverly Hills

This study will evaluate the long-term safety and tolerability of the Port Delivery System with ranibizumab (PDS) (100 mg/mL) in participants with neovascular age-related macular degeneration (nAMD) who have either completed Phase II Study GX28228 (Ladder), Phase III Study GR40548 (Archway), Phase IIIb Study WR42221 (Velodrome), or completed Week 24 visit in Study WR42221 but were not eligible to be randomized in WR42221.

Sponsor: Hoffmann-La Roche

Who Can Participate

Inclusion Criteria

Previous enrollment in and completion of Study GX28228 (Ladder) or Study GR40548 (Archway), without early treatment or study discontinuation in either study OR Previous enrollment in Study WR42221 (Velodrome) and either not eligible to be randomized in Study WR42221 at Week 24 or completed the study (from the Q24W or Q36W arm)

Ability and willingness to undertake all scheduled visits and assessments

For women of childbearing potential: agreement to remain abstinent or use contraceptive measures

Exclusion Criteria

Pregnant or breastfeeding, or intending to become pregnant during the treatment period and for at least 28 days after the last intravitreal injection of ranibizumab or 1 year after the last Implant refill-exchange of ranibizumab

History of other ocular diseases that give reasonable suspicion of a disease or condition that contraindicates the use of ranibizumab, that might affect interpretation of the results of the study or that renders the participant at high risk for treatment complications

History of other diseases, metabolic dysfunction, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of ranibizumab or placement of the Implant and that might affect interpretation of the results of the study or that renders the participant at high risk of treatment complications

Requirement for continuous use of any medications or treatments indicated in the "Prohibited Therapy" Sub-study 1 Inclusion Criteria \- For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures Participants must meet the following ocular criteria for the study eye for substudy entry:

Diagnosis of exudative nAMD within 2 years prior to the enrollment visit

Previous treatment with at least two anti-VEGF ITV injections (e.g., ranibizumab, bevacizumab, or aflibercept) for nAMD per standard of care within 6 months prior to the enrollment visit

Demonstrated response to prior anti-VEGF ITV treatment since diagnosis, as evidenced at enrollment by the following: Overall decrease in nAMD disease activity detected on SD-OCT AND Stable or improved best-corrected visual acuity (BCVA)

All subtypes of nAMD lesions are permissible (i.e., type I, type II, type III, or mixed forms per optical coherence tomography (OCT) classification) 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 analysis and grading by the central reading center of FP and SD-OCT images. Exclusion Criteria Prior Ocular Treatments Study Eye

History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD

Prior treatment with Visudyne, external-beam radiation therapy, or transpupillary thermotherapy

Previous treatment with corticosteroid ITV injection

Previous intraocular device implantation

Previous laser (any type) used for AMD treatment Either Eye

Treatment with anti-VEGF agents other than ranibizumab within 1 month prior to the enrollment visit

Prior participation in a clinical trial involving anti-VEGF drugs within 6 months prior to the enrollment visit, other than ranibizumab CNV Lesion Charateristics Study Eye

Subretinal hemorrhage that involves the center of the fovea, if the hemorrhage is greater than 0.5 disc area (1.27 mm2 ) in size at screening

Subfoveal fibrosis or subfoveal atrophy Either Eye \- CNV due to other causes, such as ocular histoplasmosis, trauma, or pathologic myopia Concurrent Ocular Conditions Study Eye

Retinal pigment epithelial tear

Any concurrent intraocular condition (e.g., cataract, glaucoma, diabetic retinopathy, or epiretinal membrane) that would either require surgical intervention during the study to prevent or treat visual loss that might result from that condition or affect interpretation of study results

Active intraocular inflammation (grade trace or above)

History of vitreous hemorrhage

History of rhegmatogenous retinal detachment

History of rhegmatogenous retinal tears or peripheral retinal breaks within 3 months prior to the enrollment visit

Aphakia or absence of the posterior capsule

Previous violation of the posterior capsule is also an exclusion criterion unless it occurred as a result of yttrium-aluminum garnet (YAG) laser posterior capsulotomy in association with prior, posterior chamber intraocular lens implantation.

Spherical equivalent of the refractive error demonstrating more than 8 diopters of myopia

Preoperative refractive error that exceeds 8 diopters of myopia, for participants who have undergone prior refractive or cataract surgery in the study eye

Intraocular surgery (including cataract surgery) within 3 months preceding the enrollment visit

Uncontrolled ocular hypertension or glaucoma and any such condition the investigator determines may require a glaucoma-filtering surgery during a patient's participation in the study

History of glaucoma-filtering surgery, tube shunts, or microinvasive glaucoma surgery

History of corneal transplant

History of prior vitrectomy surgery and absence of posterior capsule Either Eye

History of idiopathic or autoimmune-associated uveitis

Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis Concurrent Systemic Conditions

Inability to comply with study schedule or procedures as described in the study protocol

Uncontrolled blood pressure

History of stroke within the last 3 months prior to informed consent

Uncontrolled atrial fibrillation within 3 months of informed consent

History of myocardial infarction within the last 3 months prior to informed consent

History of other disease, metabolic dysfunction, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of ranibizumab or placement of the implant and that might affect interpretation of the results of the study or renders the patient at high risk of treatment complications in the opinion of the investigator

Current systemic treatment for a confirmed active systemic infection

Use of any systemic anti-VEGF agents

Chronic use of oral corticosteroids

Active cancer within 12 months of enrollment

Previous participation in any non-ocular (systemic) disease studies of investigational drugs within 1 month preceding the informed consent (excluding vitamins and minerals)

Use of antimitotic or antimetabolite therapy within 30 days or 5 elimination half-lives of the enrollment visit

History of albinism

Pregnant or breastfeeding, or intending to become pregnant during the treatment period and for at least 28 days after the last ITV injection of ranibizumab or 1 year after the last implant refill-exchange of ranibizumab Sub-study 2 Inclusion Criteria:

Having experienced septum dislodgement in the original implant while in the main study or after exiting the main study Ocular Inclusion Criteria for Study Eye

Sufficiently clear ocular media and adequate pupillary dilation to allow for analysis and grading by central reading center Exclusion Criteria (Cohort 1 only): Concurrent Ocular Conditions-Study Eye

Any ocular condition that may render the patient at high risk for surgical or treatment complications

Intraocular surgery (including cataract surgery) within 1 month preceding the enrollment visit

Any use of medicated intraocular implants (other than the PDS implant), at any time prior to enrollment

History of rhegmatogenous retinal tears or peripheral retinal breaks within 3 months prior to the enrollment visit

Any concurrent ocular condition that would require surgical intervention during the study to prevent or treat visual loss

Concurrent conjunctival, Tenon's capsule, and/or scleral condition in the supero-temporal quadrant of the eye (e.g., scarring, thinning, mass) that may affect the refill-exchange procedure of the PDS implant

Ongoing ocular complications that might affect participant safety Concurrent Ocular Conditions-Either Eye

Suspected or active ocular or periocular infection

Any history of uveitis

Active blepharitis Concurrent Systemic Conditions

Recent history (in the last 3 months prior to enrollment) of other disease, other non-diabetic metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a condition that contraindicates the use of ranibizumab or surgical placement of the PDS implant; that might affect interpretation of the results of the study; or that renders the participant at high risk for treatment complications

Active cancer within the last 12 months, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or prostate cancer

Current systemic treatment for a confirmed active systemic infection - Participation in an investigational trial that involves treatment with any drug or device (with the exception of vitamins and minerals or enrollment in the main study GR40549) within 6 months prior to enrollment.

Use of antimitotic or antimetabolite therapy within 30 days or 5 elimination half-lives.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Beverly Hills?

Yes, this clinical trial (NCT03683251) has an active research site in Beverly Hills, CA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Macular Degeneration Treatment Options in Beverly Hills, CA

If you're searching for macular degeneration treatment options in Beverly Hills, CA, this clinical trial (NCT03683251) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Beverly Hills research site is actively enrolling participants for this phase 3 clinical trial. You'll receive care from experienced macular degeneration specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all macular degeneration clinical trials near you to find additional studies recruiting in your area.

Macular Degeneration Clinical Trial in Beverly Hills, CA

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