Safety and Efficacy of ADVM-022 in Treatment-Experienced Patients With Neovascular Age-related Macular Degeneration [LUNA]

Launched by ADVERUM BIOTECHNOLOGIES, INC. · Sep 8, 2022

Keywords

ClinConnect Summary

The LUNA clinical trial is studying a new treatment called ADVM-022 for patients with neovascular age-related macular degeneration (nAMD), a condition that can lead to vision loss due to abnormal blood vessels in the eye. This trial aims to see if a single injection of ADVM-022 can provide a longer-lasting effect compared to the current treatment, which requires regular injections every few weeks. By reducing the need for these frequent visits, the hope is to improve patient care and prevent vision loss.

To be eligible for this trial, participants need to be at least 50 years old and must have shown a good response to previous anti-VEGF treatments, which help manage nAMD. They should also have received at least two injections in the past four months and meet specific vision criteria in both their study eye and non-study eye. Participants will receive the new treatment and will be monitored for its safety and effectiveness. It's important to note that certain health conditions or recent treatments may exclude someone from participating in the trial.

Gender

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Eligibility criteria

• Inclusion Criteria:
• • Male or female participants, ≥ 50 years of age
• • Willing and able to provide written, signed informed consent for this study
• • Demonstrated a meaningful response to anti-VEGF therapy
• • Participants must be under active anti-VEGF treatment for wet AMD and received a minimum of 2 injections within 4 months prior to screening for the treatment of choroidal neovascularization secondary to nAMD in the study eye
• • Vision of the study eye at Baseline: BCVA in the range of 25 - 83 ETDRS letters, inclusive (approximate Snellen equivalent visual acuity range of 20/25 - 20/320)
• • Vision of the non-study eye at Baseline: BCVA ≥ 35 ETDRS letters (approximate Snellen equivalent of 20/200 or better)
• Exclusion Criteria:
• • Any condition that could affect the interpretation of results or render the participant at high risk of treatment complications in the opinion of the Investigator
• • Ocular or periocular infection or intraocular inflammation in either eye within 1 month prior to or at the Randomization Visit (Day -7)
• • Uncontrolled diabetes or HbA1c ≥ 7.0 %
• • History or evidence of significant uncontrolled concomitant disease within 6 months of the Screening visit
• • Any history of ongoing bleeding disorders or INR \>3.0
• • History or evidence of macular or retinal disease other than nAMD
• • History or evidence of retinal detachment or retinal pigment epithelium rip/tear
• • Uncontrolled ocular hypertension or glaucoma
• • Prior treatment with photodynamic therapy or retinal laser for the treatment of nAMD
• • Any history of vitrectomy or any other vitreoretinal surgery
• • Prior treatment with gene therapy at any time or any non-gene therapy investigational treatment or medical device in the study eye within 3 months of the Screening Visit or 5 half-lives of the investigational medicinal product