25/09/2022.MANTRA: evaluating the association between retinal sensitivity and retinal flow in AMD

Description

Multicenter prospective observational study to evaluate the association between retinal sensitivity and retinal flow in age-related macular degeneration (AMD).

Goal

The present study aims to evaluate the relationship between retinal sensitivity measured with MAIA Microperimetry and coexisting retinal fluid measured with OCT Spectralis in patients with macular degeneration candidates for anti-VEGF treatments according to clinical practice.

Inclusion criteria

• Age ≥ 50 years.
• Bilateral or unilateral AMD diagnosis.
• Maximum corrected visual acuity ≥ 20/63.
• Presence of predominantly active type I lesion.
• Not having received any anti-VEGF treatment previously.

Duration

Patients will be followed for 18 months.

22/05/2022.VELODROME: efficacy, safety and pharmacokinetics of ranibizumab 100 mg/ml through a PDS in patients with nDMAE

Description

This study will evaluate the efficacy, safety and pharmacokinetics of ranibizumab 100 mg/ml released through a port-delivery system (PDS) will refill each 6 weeks as compared with a refill each 24 months in patients with neovascular age-related macular degeneration (nAMD).

Aim

The main objective is to evaluate the efficacy of ranibizumab 100 mg/ml delivered through a PDS system with refills at week 36 as compared to that at week 24.

Inclusion criteria

Patients older than 50 years diagnosed with nAMD in the 9 months prior to the selection visit. These patients need to receive a minimum of 3 intravitreal injections in the prior 6 months with proven response to therapy. If this last criterion is not met, the patient may enter a run-in phase where she/he will receive the minimum number of injections to met these requirements.

Duration

Between 24 and 36 weeks.

15/05/2022.TALON (Extension): efficacy and safety of brolucizumab 6 mg in a maximum interval dosing schedule of 20 weeks for patients with nDMAE

Description

A phase IIIb/IV open-label extension study with a single arm of 56 weeks to evaluate the efficacy and safety of brolucizumab 6 mg in a maximum interval dosing schedule of 20 weeks for the treatment of patients with neovascular age-related macular degeneration (nAMD) that completed the CRTH258A2303 (TALON) study.

Aims

• To evaluate the efficacy and safety of brolucizumab in patients with nAMD to evaluate the potential for achieving an interval of up to 20 weeks between intravitreal injections.
• To evaluate the durability of brolucizumab up to the week 56.
• To determine the functional effects of brolucizumab as measured on the change of best-corrected visual acuity between baseline and the mean of weeks 52 and 56.

Drug

Brolucizumab 6 mg/0,05 Ml.

Inclusion criteria

Participants who have successfully completed the TALON study up to week 64 (end of study visit).

Duration

56 weeks.

15/05/2022.GALE: evaluating the long-term safety and efficacy of intravitreal pegcetacoplan in patients with GA secondary to AMD

Description

Its'a Phase III, open-label, multicenter clinical trial evaluating the long-term safety and efficacy of intravitreal pegcetacoplan in patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD).

Goal

The main objective of this study is to evaluate the long-term safety of intravitreal pegcetacoplan, as well as the changes in the lesion measured by autofluorescence.

Drug

Biochemical, genetic and clinical lines of evidence in humans indicate that the complement system plays a role in the aetiology of AMD. Complement protein C3 (which has a pro-inflammatory action), membrane attack complex and complement factor H are present in the drusen and basal laminar deposits of patients with AMD. Pegcetacoplan is a drug for intravitreal use that blocks the action of C3. The main action is anti-inflammatory.

Inclusion criteria

This study only accepts patients who have participated in the APL2-103 study or have completed the 24-month treatment of the APL2-303 (DERBY) or APL2-304 (OAKS) studies.

Duration

The duration of the trial is three years.