A Phase 2 interventional study of IONIS-FB-Lrx and Placebo (sterline saline 0.9%) in Geographic Atrophy and Age Related Macular Degeneration, sponsored by Ionis Pharmaceuticals, Inc.. Withdrawn at 37 sites in 3 countries. Open to participants aged 55 Years and older. Per ClinicalTrials.gov, last updated 2019-08-13.
Sponsored by Ionis Pharmaceuticals, Inc. · Phase 2, Interventional, and Treatment
Among 131 studies in Geographic Atrophy with a site in United States — 35 open to participants now, 45 under way, 5 of them phase 3. Geographic Atrophy · United States.
Among the 131 studies in Geographic Atrophy with a site in United States, this one is the 105th largest by enrollment of the 107 interventional ones that give a count, is one of 8 that started in 2018, is one of 43 in phase 2, and was the 52nd registered.
188 studies on the registry are indexed under Geographic Atrophy; 52 are open to participants now.
Browse Geographic Atrophy studies →35 of the 131 studies in Geographic Atrophy with a site in United States are open now. Recruiting first, the newest first:
Genentech, Inc. · Sites in United States
Ages 50+
Biojiva LLC · Sites in United States, Australia
Ages 55+
Sitala Bio LTD · Sites in United States, Argentina, Australia and 4 more countries
Ages 60+
University of Utah · Sites in United States
Ages 65–90
Cellio Therapeutics Inc · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 40 Geographic Atrophy studies recruiting now, 31 (78%) set no upper age limit and none (0%) stop at 75 or younger; 2 take children under 18; 4 take healthy volunteers.
This study: 55 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
131 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 33 · Phase 2 65 · Phase 3 20
First in 2000; this study’s year is marked. 8 started in 2018.
By drug class, each counting the studies that test any of its medicines:
Median enrollment 98 across the 107 interventional studies, 138 across the 24 observational. Of the 79 that completed or were terminated, 40 (51%) have results posted.
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109 of 131 have an industry lead sponsor. The 10 most frequent:
Ionis Pharmaceuticals, Inc. is the lead sponsor of 118 studies on the registry; 10 are open to participants now.
Of its 49 completed or terminated interventional studies of FDA-regulated products, 22 (45%) have results posted.
Ionis Pharmaceuticals, Inc. has 2 studies filed under Geographic Atrophy — fewer than ten, so there is no comparison to draw.
12 of the studies in Geographic Atrophy with a site in United States that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05949593Phase 3Belite Bio, IncPhase 3, Randomized, Placebo-Controlled Study of Tinlarebant to Explore Safety and Efficacy in Geographic Atrophy | 2027-06-30 |
| NCT06510816Phase 3Annexon, Inc.A Study Investigating the Efficacy and Safety of Intravitreal (IVT) Injections of Vonaprument (Formerly ANX007) in Participants With Dry Age-Related Macular Degeneration (AMD) With Geographic Atrophy (GA) | 2027-07-31 |
| NCT06769048Boehringer IngelheimA Study to Test Different Doses of BI 1584862 in People With a Distinct Form of Age-related Macular Degeneration (AMD) Called Geographic Atrophy | 2026-12-22 |
| NCT07747662University of Wisconsin, MadisonAdaptive Optics Scanning Light Ophthalmoscopy (AOSLO) and Microperimetry (MP) Sub-study | 2027-02 |
| NCT07144137Complement TherapeuticsA Non-Interventional Study Observing Short-Term Progression in Geographic Atrophy (GA) | 2027-03-31 |
Add all 12 to your calendar (.ics) → With an account.
Among the 131 studies in Geographic Atrophy with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The purpose of this study is to assess the Safety and Efficacy of IONIS-FB-Lrx for up to 120 patients with Geographic Atrophy secondary to Age Related Macular Degeneration
This study will assess changes in complement factor B over a 69-week treatment period in a patient population 55 and older with well-demarcated Geographic Atrophy secondary to Age Related Macular Degeneration
Key Inclusion Criteria:
Key Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: IONIS-FB-Lrx
Drug: Placebo (sterline saline 0.9%)
Single Dose of IONIS-FB-Lrx administered once weekly for weeks 1-3, and every other week or less frequently until week 70
Calculated volume to match active comparator. Administered subcutaneously weekly for weeks 1-3, and every other week or less frequently until week 70
Efficacy of IONIS-FB-Lrx
The Efficacy of IONIS-FB-Lrx will be measured by the percent change in plasma complement factor B level
Time frame: Up to 74 weeks
Incidence and severity of adverse events that are related to treatment with IONIS-FB-Lrx
The safety and tolerability of IONIS-FB-Lrx will be assessed by determining the incidence and severity of adverse events that are related to treatment with IONIS-FB-Lrx
Time frame: Up to 86 weeks
Proportion of patients in each treatment group achieving a >50% reduction of plasma complement factor B
Proportion of patients in each treatment group achieving a \>50% reduction of plasma complement factor B from Baseline to Post-Treatment
Time frame: Up to 74 weeks
Effect of IONIS-FB-Lrx on the rate of change of the area of GA secondary to AMD
Effect of IONIS-FB-Lrx on the rate of change of the area of GA secondary to AMD as measured by Fundus Autofluorescence from Baseline to Post-Treatment
Time frame: Up to 74 weeks
Effect of factor B reduction on other components of the complement pathways in AMD patients
Effect of factor B reduction on other components of the complement pathways such as AH50, CH50 and Bb in AMD patients from Baseline to Post-Treatment
Time frame: Up to 74 weeks
Ran from Mar 2018 to primary completion in Oct 2018, 6 months.
How these figures are worked out, and which studies are left out of them.
This study is withdrawn, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Sefaxersen sodium