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Lampalizumab · 1 trial · 1 indication
GA or the death of photoreceptors and surrounding cells in the retina, is a common condition in participants with age-related macular degeneration (AMD). The death of these photoreceptors results in lesions that cause vision loss. The change in GA lesion area was measured by FAF and analysis of FAF images was performed by the central reading center. A positive change from baseline indicates an increase in size of geographic atrophy lesion area (worsening; disease progression). BCVA=best corrected visual acuity; ETDRS=Early Treatment Diabetic Retinopathy Scale.
| Arm | Type | Description |
|---|---|---|
| Lampalizumab: Open-label Safety Run-In | EXPERIMENTAL | Participants will receive 10 milligrams (mg) lampalizumab intravitreally Q2W during the safety run-in period. |
| Q2W Lampalizumab: Randomized Treatment | EXPERIMENTAL | Participants will receive 10 mg dose of lampalizumab intravitreally Q2W during the 24-week treatment period. |
| Q4W Lampalizumab: Randomized Treatment | EXPERIMENTAL | Participants will receive 10 mg dose of lampalizumab intravitreally Q4W during the 24-week treatment period. |
| Sham: Randomized Treatment | SHAM_COMPARATOR | Participants randomized to control arms will receive sham injections, that mimics intravitreal injection of lampalizumab. |
| Name | Type | Description |
|---|---|---|
| Sham | OTHER | Sham injection will be administered as a matching intravitreal injection of lampalizumab. |
| Lampalizumab | DRUG | 10 mg dose of lampalizumab administered intravitreally |
Inclusion Criteria: * Complement Factor I (CFI) profile biomarker-positive result * Women of child bearing potential and men should remain abstinent or use contraceptive methods Exclusion Criteria: * History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD in stud...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Regeneron Pharmaceuticals, Inc. | REGN | 2 | PHASE3 | Pozelimab, Cemdisiran |
| Belite Bio, Inc. ADR | BLTE | 1 | PHASE3 | Tinlarebant |
| Annexon, Inc. | ANNX | 2 | PHASE3 | Vonaprument (ANX007) |
| Johnson & Johnson | JNJ | 1 | PHASE2 | JNJ-81201887 |
| AbbVie, Inc. | ABBV | 1 | PHASE1 | ABBV-6628 |
| Sanofi SA Sponsored ADR | SNY | 1 | PHASE1 | SAR446597 |
| Ocugen Inc | OCGN | 1 | PHASE1 | OCU410 |
| Genentech, Inc. | RHHBY | 1 | PHASE2 | OpRegen |
| Apellis Pharmaceuticals, Inc. | APLS | 1 | - | Pegcetacoplan |
Lampalizumab is an investigational monoclonal antibody being studied for the treatment of geographic atrophy, an advanced form of age-related macular degeneration. It is administered as an intravitreal injection into the eye. The drug has been evaluated in a Phase 2 clinical trial in participants with geographic atrophy.
Lampalizumab targets complement factor D (CFD) and acts as an inhibitor. By inhibiting CFD, the drug is designed to modulate the complement system, which is thought to play a role in the progression of geographic atrophy. The target is also known as adipsin.
Lampalizumab is being developed by Roche Holding AG, which trades under the ticker RHHBY. Roche is a Swiss multinational healthcare company. The drug is part of Roche's ophthalmology pipeline.
Lampalizumab is in Phase 2 clinical development. It has not been approved by the FDA for any indication. The Phase 2 trial for geographic atrophy has been completed.
Lampalizumab has been studied in a Phase 2 clinical trial, NCT02288559, titled "A Study of Lampalizumab Intravitreal Injections Administered Every Two Weeks or Every Four Weeks to Participants With Geographic Atrophy." The trial enrolled 96 participants, was randomized and sham-controlled, and was conducted in the United States. It is now completed.
Lampalizumab is also known by its development code, which is not provided here. It is a distinct monoclonal antibody targeting complement factor D. No other names are available.