CompletedPhase 1

Safety And Tolerability Study Of RN6G In Subjects With Advanced Dry, Age-Related Macular Degeneration Including Geographic Atrophy

United States24 participantsStarted 2010-08-05

Plain-language summary

The purpose of this study is to determine the safety and tolerability of multiple doses of RN6G in subjects with advanced dry, age-related macular degeneration including geographic atrophy.

Who can participate

Age range

60 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Be of non-child bearing potential * Diagnosis of dry AMD including uni- or multi-focal geographic atrophy without foveal involvement * BCVA of 20/50 or better in the study eye Exclusion Criteria: * Evidence of ocular disease other than advanced AMD or GA in the study eye * History or diagnosis of exudative (wet) AMD, with subretinal or choroidal neovascular lesions in the study eye * Presence of disease or condition that might compromise the cardiovascular, hematological, renal, hepatic, pulmonary, endocrine, central nervous immune, or gastrointestinal system * Requires ocular or systemic medications that are known to be toxic to the lens, retina or optic nerve

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Participants With Toxicity or Intolerable Dose Criteria

Timeframe: Baseline up to Day 304/End of Treatment (ET)

Number of Participants With Treatment Emergent Adverse Events (TEAEs) Categorized by Severity

Timeframe: Baseline up to Day 304/ET

Number of Participants With Treatment Emergent Adverse Events (TEAEs): All Causalities and TEAEs Categorized by Causal Relationship to Study Drug

Timeframe: Baseline up to Day 304/ET

Number of Participants With Ocular Treatment Emergent Adverse Events (TEAEs) Categorized by Severity

Timeframe: Baseline up to Day 304/ET

Number of Participants With Ocular Treatment Emergent Adverse Events (TEAEs) Categorized by Causal Relationship to Study Drug

Timeframe: Baseline up to Day 304/ET

Number of Participants With Systemic Treatment Emergent Adverse Events (TEAEs) Categorized by Severity

Timeframe: Baseline up to Day 304/ET

Trial details

NCT IDNCT01003691

SponsorPfizer

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2013-03-05

Results submitted2021-11-09

View on ClinicalTrials.gov More Age-Related Maculopathy trials

Who can participate

Age range

60 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Number of Participants With Toxicity or Intolerable Dose Criteria

Timeframe: Baseline up to Day 304/End of Treatment (ET)

Number of Participants With Treatment Emergent Adverse Events (TEAEs) Categorized by Severity

Timeframe: Baseline up to Day 304/ET

Number of Participants With Treatment Emergent Adverse Events (TEAEs): All Causalities and TEAEs Categorized by Causal Relationship to Study Drug

Timeframe: Baseline up to Day 304/ET

Number of Participants With Ocular Treatment Emergent Adverse Events (TEAEs) Categorized by Severity

Timeframe: Baseline up to Day 304/ET

Number of Participants With Ocular Treatment Emergent Adverse Events (TEAEs) Categorized by Causal Relationship to Study Drug

Timeframe: Baseline up to Day 304/ET

Number of Participants With Systemic Treatment Emergent Adverse Events (TEAEs) Categorized by Severity

Timeframe: Baseline up to Day 304/ET