Are You An Anchor Study Expert?

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| By Ken Ashacker

Ken Ashacker

Community Contributor

Quizzes Created: 1 | Total Attempts: 23

| Attempts: 23 | Questions: 15

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1. Who was the primary investigator for the year 2 results of the ANCHOR study?

Sanjoy T. Khan

David M. Brown

Lester B. Pearson

James S. Sykes

Dr. Brown practices at Retina Consultants Houston. He has been a continuous selection as one of the “Best Doctors in America” from 2007 -2018.

Explanation

Dr. Brown practices at Retina Consultants Houston. He has been a continuous selection as one of the “Best Doctors in America” from 2007 -2018.

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About This Quiz

Are you an ANCHOR Study expert? This quiz tests your knowledge on the ANCHOR study, focusing on its primary investigator, objectives, design, outcome measures, and participant groups. It... see moreis essential for learners in medicine, particularly in ophthalmology and clinical research. see less

2. What were the main outcome measures of the ANCHOR study?

Number of injections over 24 months; change in Visual Acuity (VA) from baseline

% losing < 10 letters from baseline; % gaining 10 letters or more in VA; FA-assessed lesion characteristics

% losing < 15 letters from baseline; % gaining 15 letters or more in VA; FA-assessed lesion characteristics

% losing 5 or more letters; % gaining more than 10 letters; number of injections

The main outcome measures of the ANCHOR study were the percentage of participants who lost less than 15 letters from baseline in Visual Acuity (VA), the percentage of participants who gained 15 letters or more in VA, and the assessment of lesion characteristics using fluorescein angiography (FA).

Explanation

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3. What was the objective of the ANCHOR study?

Compare Lucentis with Avastin and Eylea

Compare Ranibizumab and Aflibercept in the treatment of predominantly classic CNV (Choroidal Neovascularization)

Compare 0.3 and 0.5 mg doses of Ranibizumab in treating predominantly Occult CNV

Compare Ranibizumab with Verteporfin Photodynamic Therapy (PDT) in treating predominantly classic CNV

The objective of the ANCHOR study was to compare the effectiveness of Ranibizumab with Verteporfin Photodynamic Therapy (PDT) in treating predominantly classic CNV.

Explanation

The objective of the ANCHOR study was to compare the effectiveness of Ranibizumab with Verteporfin Photodynamic Therapy (PDT) in treating predominantly classic CNV.

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4. How many patients started the ANCHOR Study and what % finished?

198; 91%

243; 74%

423; 77%

514; 82%

In the ANCHOR Study, a total of 423 patients started the study. Out of these patients, 77% successfully completed the study.

Explanation

In the ANCHOR Study, a total of 423 patients started the study. Out of these patients, 77% successfully completed the study.

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5. What were the 3 groups that took part in the ANCHOR study?

Verteporfin PDT plus monthly sham intraocular injection; Sham Verteporfin PDT plus monthly 0.3 mg Ranibizumab intraocular injection ; Sham Verteporfin... Verteporfin PDT plus monthly sham intraocular injection; Sham Verteporfin PDT plus monthly 0.3 mg Ranibizumab intraocular injection ; Sham Verteporfin PDT plus monthly 0.5 mg Ranibizumab intraocular injection

Sham Verteporfin PDT plus monthly 0.3 mg Ranibizumab intraocular injection ; Sham Verteporfin PDT plus monthly 0.5 mg Ranibizumab intraocular... Sham Verteporfin PDT plus monthly 0.3 mg Ranibizumab intraocular injection ; Sham Verteporfin PDT plus monthly 0.5 mg Ranibizumab intraocular injection

Monthly Avastin intraocular injection; Sham Verteporfin PDT plus monthly 0.3 mg Ranibizumab intraocular injection ; Sham Verteporfin PDT plus monthly... Monthly Avastin intraocular injection; Sham Verteporfin PDT plus monthly 0.3 mg Ranibizumab intraocular injection ; Sham Verteporfin PDT plus monthly 0.5 mg Ranibizumab intraocular injection

Verteporfin PDT plus monthly sham intraocular injection; Sham Verteporfin PDT plus monthly 0.3 mg Ranibizumab intraocular injection

The ANCHOR study involved three groups of participants. The first group received Verteporfin PDT plus monthly sham intraocular injection. The second group received Sham Verteporfin PDT plus monthly 0.3 mg Ranibizumab intraocular injection. The third group received Sham Verteporfin PDT plus monthly 0.5 mg Ranibizumab intraocular injection.

Explanation

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6. What was the design of the ANCHOR study?

Single country, triple masked, randomized study

Multi-Center, international, randomized, double masked, active treatment, controlled clinical trial.

North American, double masked, 12 month, randomized study

Global, single masked, retroactive clinical study

The design of the ANCHOR study was a multi-center, international, randomized, double masked, active treatment, controlled clinical trial. This means that the study was conducted in multiple centers across different countries, participants were randomly assigned to different treatment groups, both the participants and the researchers were unaware of the treatment assignments (double masked), the study included an active treatment group, and there was a control group for comparison. This design allows for a rigorous evaluation of the effectiveness and safety of the treatment being studied.

Explanation

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7. What other study, along with the ANCHOR Study, let to the United States Food & Drug Administration approval of Ranibizumab for treatment of all angiographic subtypes of CNV secondary to AMD in June 2006?

TREND

TREX

MARINA

FIREFOX

MARINA stands for “Minimally Classic/Occult Trial of the Anti-VEGF Antibody Ranibizumab in the Treatment of Neovascular Age Related Macular Degeneration

Explanation

MARINA stands for “Minimally Classic/Occult Trial of the Anti-VEGF Antibody Ranibizumab in the Treatment of Neovascular Age Related Macular Degeneration

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8. What was the rate of presumed endophtalmitis in the study eye per injection?

1.4%

2.2%

0.05%

0.0003%

The rate of presumed endophthalmitis in the study eye per injection was 0.05%. This means that out of every 100 injections, 0.05 of them resulted in presumed endophthalmitis. This is a relatively low rate, indicating that the risk of developing presumed endophthalmitis after an injection in the study eye is quite low.

Explanation

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9. What was the pivotal finding of the ANCHOR study?

A cardiovascular therapy could be used effectively in retina patients.

Off label use of Avastin for retina therapy was almost as effective as Ranibizumab.

This proved that anti-VEGf therapy was effective in preventing cataracts.

This was the 1st demonstration that a therapy could not only prevent further VA loss but also provide clinically meaningful... This was the 1st demonstration that a therapy could not only prevent further VA loss but also provide clinically meaningful improvement in VA in a substantial proportion of patients with predominately classic CNV.

The pivotal finding of the ANCHOR study was that a therapy could not only prevent further visual acuity (VA) loss but also provide clinically meaningful improvement in VA for a significant number of patients with predominately classic choroidal neovascularization (CNV). This finding was significant because it showed that the therapy had the potential to not only halt the progression of vision loss but also to improve vision in a substantial proportion of patients with this specific condition.

Explanation

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10. Prior to the approval of verteporfin in 2001, what was the expected outcome for patients with classic Choroidal Neovascularization (CNV)?

Deterioration of all vision but not likely to be classified as legally blind

Temporary loss of the majority of non central vision

Permanent loss of the majority of central vision within 3 to 9 months of diagnosis

Loss of Drivers Licence

Many people rate a loss of sight as being more severe than death.

Explanation

Many people rate a loss of sight as being more severe than death.

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11. What was the overall result in change in VA from baseline for the 3 groups in the ANCHOR Study at the end of 24 months?

0.3 mg Ranibizumab gained 10.7 letters on average; 0.5 mg Ranibizumab gained 8.1 on average; PDT LOST 9.8 letters on... 0.3 mg Ranibizumab gained 10.7 letters on average; 0.5 mg Ranibizumab gained 8.1 on average; PDT LOST 9.8 letters on average 1

0.3 mg Ranibizumab gained 8.1 letters on average; 0.5 mg Ranibizumab gained 10.7 on average; PDT gained 9.8 letters on... 0.3 mg Ranibizumab gained 8.1 letters on average; 0.5 mg Ranibizumab gained 10.7 on average; PDT gained 9.8 letters on average

0.3 mg Ranibizumab gained 10.1 letters on average; 0.5 mg Ranibizumab gained 10.7 on average; PDT gained 10.8 letters on... 0.3 mg Ranibizumab gained 10.1 letters on average; 0.5 mg Ranibizumab gained 10.7 on average; PDT gained 10.8 letters on average

0.3 mg Ranibizumab gained 8.1 letters on average; 0.5 mg Ranibizumab gained 10.7 on average; PDT LOST 9.8 letters on... 0.3 mg Ranibizumab gained 8.1 letters on average; 0.5 mg Ranibizumab gained 10.7 on average; PDT LOST 9.8 letters on average

Imagine. The difference from the 0.5 mg Ranibizumab group and the PDT group was nearly 20 letters or 4 lines!

Explanation

Imagine. The difference from the 0.5 mg Ranibizumab group and the PDT group was nearly 20 letters or 4 lines!

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12. What was the primary efficacy endpoint of the ANCHOR study? (Primary end point was at 12 months. All other efficacy endpoints were secondary including those at 24 months).

Proportion of patients who at 12 months lost fewer than 15 letters (~3 lines) from baseline.

Proportion of patients who at 12 months gained more than 15 letters (~3 lines) from baseline.

Proportion of patients who at 12 months lost fewer than 15 letters (~3 lines) or gained more than 15 (~3... Proportion of patients who at 12 months lost fewer than 15 letters (~3 lines) or gained more than 15 (~3 lines) letters from baseline.

Proportion of patients who had more than 100 microns of thinning of the retina from baseline at 12 months.

The primary efficacy endpoint of the ANCHOR study was to determine the proportion of patients who, at 12 months, lost fewer than 15 letters (~3 lines) from baseline. This means that the study aimed to measure the number of patients who experienced a decrease in visual acuity of less than 15 letters on an eye chart after 12 months of treatment. This endpoint is important in evaluating the effectiveness of the treatment in maintaining or improving vision in patients with the condition being studied.

Explanation

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13. How many sites were used in the ANCHOR study?

112

In the ANCHOR study, a total of 83 sites were used.

Explanation

In the ANCHOR study, a total of 83 sites were used.

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14. How many subjects had both eyes in the study?

The answer is 0 because the question is asking for the number of subjects who had both eyes in the study. Since the options provided do not include any number greater than 0, it can be concluded that none of the subjects had both eyes in the study.

Explanation

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15. What was the letter/gain loss of the Ranibizumab groups at Day 7?